Amivantamab History and Updates

228 events · 2005 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: August 31, 2026.

FDA Approvals

Label Revisions

149

Trial Milestones

Pivotal Publications

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-09-01Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Amivantamab since 2005, drawn from openFDA, ClinicalTrials.gov, and PubMed.

All published updates (28)

2026

Label revisionOcrevus Zunovo label adds relapsing MS indication· Aug 17, 2026
Label revisionAmivantamab Label Adds Boxed Warning for Cardiomyopathy, Toxicity· May 29, 2026
Label revisionAmivantamab (Rybrevant) Label Adds Boxed Warning for Cardiomyopathy· May 21, 2026
Results postedAmivantamab Shows Limited Overall Response in Adenoid Cystic Carcinoma Trial· May 8, 2026
FDA approval (supplemental)Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase) Receives FDA…· May 8, 2026
FDA approvalRybrevant Faspro FDA Approved as New Formulation of Amivantamab· Feb 13, 2026
Results postedRybrevant Subcutaneous Formulation Shows Higher Serum Levels in EGFR+ NSCLC· Feb 2, 2026
FDA approval (supplemental)Darzalex Faspro: FDA Grants Supplemental Efficacy Approval· Jan 27, 2026

2025

FDA approvalRybrevant Faspro: FDA Approves New Amivantamab Formulation· Dec 17, 2025
FDA approval (supplemental)Darzalex Faspro Gains FDA Supplemental Efficacy Approval· Nov 19, 2025
Label revisionAmivantamab Label Updated for First-Line NSCLC with EGFR Exon 20 Insertion· Nov 11, 2025
FDA approval (supplemental)Darzalex Faspro (daratumumab and hyaluronidase-fihj) FDA Supplemental Efficacy…· Nov 6, 2025
Results postedAmivantamab: Dexamethasone 8 mg Reduces Infusion Reactions in NSCLC Trial· Oct 20, 2025
FDA approval (supplemental)Vyvgart Hytrulo Receives FDA Supplemental Approval for Efficacy· Oct 17, 2025
FDA approval (supplemental)Amivantamab: FDA Approves Supplemental Application for Efficacy· Aug 14, 2025
Results postedAmivantamab + Lazertinib + Chemo Improves PFS in EGFR+ NSCLC Post-Osimertinib· Apr 16, 2025
FDA approval (supplemental)Vyvgart Hytrulo: FDA Grants Supplemental Efficacy Approval· Apr 10, 2025

2024

FDA approval (supplemental)Phesgo: FDA Approves Supplemental Application for Efficacy· Nov 22, 2024
FDA approval (supplemental)Vyvgart Hytrulo FDA Approves Supplemental Efficacy Application· Aug 8, 2024
FDA approval (supplemental)Vyvgart Hytrulo (efgartigimod alfa) Gains Supplemental FDA Efficacy Approval· Jun 21, 2024
FDA approval (supplemental)Herceptin Hylecta Gains Supplemental FDA Efficacy Approval· Jun 18, 2024
Primary completionAmivantamab Subcutaneous Formulation Bioequivalent to IV in Advanced NSCLC· Jan 3, 2024

2023

Primary completionAmivantamab + Lazertinib Improves PFS in EGFR+ NSCLC vs Osimertinib· Aug 11, 2023
Primary completionAmivantamab + Lazertinib Combo Doubles NSCLC PFS vs Chemo Alone· Jul 10, 2023
FDA approvalVyvgart Hytrulo (Efgartigimod Alfa/Hyaluronidase) Gains Initial FDA Approval· Jun 20, 2023
Primary completionAmivantamab + Chemo Improves PFS in EGFR Exon 20 NSCLC Phase 3 Trial· May 3, 2023

2020

FDA approvalPhesgo (pertuzumab, trastuzumab, hyaluronidase) Gains Initial FDA Approval· Jun 29, 2020

2019

FDA approvalHerceptin Hylecta (trastuzumab and hyaluronidase-oysk) Receives FDA Approval· Feb 28, 2019

Upcoming & expected milestones

Primary completionNov 30, 2026· ClinicalTrials.gov

Phase 2 primary completion: NCT05117931

A Study of Amivantamab in People With Esophagogastric Cancer

Primary completionDec 31, 2026· ClinicalTrials.gov

Phase 1 primary completion: NCT02609776

Study of Amivantamab, a Human Bispecific EGFR and cMet Antibody, in Participants With Advanced Non-Small Cell Lung Cancer

Primary completionDec 31, 2026· ClinicalTrials.gov

Phase 1 primary completion: NCT06816992

ORIC-114 in Combination With Subcutaneous Amivantamab in Patients With EGFR Exon20 Insertion Mutant NSCLC

Primary completionJan 31, 2027· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT05908734

A Study of Combination Therapy With Amivantamab and Cetrelimab in Participants With Metastatic Non-small Cell Lung Cancer

Primary completionJan 31, 2027· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT05845671

Amivantamab With Tyrosine Kinase Inhibitors (TKI) for Advanced NSCLC With ALK, ROS1, or RET Alterations

Primary completionFeb 12, 2027· ClinicalTrials.gov

Phase 1 primary completion: NCT04077463

A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer

Primary completionApr 27, 2027· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT05379595

A Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic Colorectal C

Primary completionApr 28, 2027· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT05488314

A Study of Amivantamab and Capmatinib Combination Therapy in Unresectable Metastatic Non-small Cell Lung Cancer

Primary completionMay 31, 2027· ClinicalTrials.gov

Phase 2 primary completion: NCT06855849

An Open-label, Single-arm, Multicenter Phase II Study to Evaluate the Efficacy of Amivantamab in Combination With FOLFIRI as a Second-line T

Primary completionMay 31, 2027· ClinicalTrials.gov

Phase 2 primary completion: NCT06120140

Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NS

Primary completionJul 1, 2027· ClinicalTrials.gov

Phase 1 primary completion: NCT06632236

5G-EMERALD: Amivantamab in Malignant Brain Tumours

Primary completionJul 31, 2027· ClinicalTrials.gov

Phase 2 primary completion: NCT06784791

Preoperative Amivantamab or Amivantamab and Carboplatin/Pemetrexed Treatment in Patients With Resectable Non-small-cell Lung Cancer Harborin

Primary completionAug 17, 2027· ClinicalTrials.gov

Phase 2 primary completion: NCT05498428

A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated No

Primary completionOct 1, 2027· ClinicalTrials.gov

Phase 2 primary completion: NCT05801029

A Study to Investigate Safety and Efficacy of Osimertinib and Amivantamab in Participants With Non-small Cell Lung Cancer With Common Epider

Primary completionOct 31, 2027· ClinicalTrials.gov

Phase 2 primary completion: NCT07392658

Phase II Trial of Amivantamab Plus Monochemotherapy in Platinum Unfit NSCLC Patients With EGFR exon20 Insertion Mutations.

Primary completionDec 15, 2027· ClinicalTrials.gov

Phase 3 primary completion: NCT06750094

A Study of Amivantamab and FOLFIRI Versus Cetuximab/Bevacizumab and FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Colorectal Can

Primary completionDec 27, 2027· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT06385080

A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer

Primary completionDec 31, 2027· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT06083857

PhI/II Study of Amivantamab and Tepotinib Combo in MET-altered Non-small Cell Lung Cancer

Primary completionMar 2, 2028· ClinicalTrials.gov

Phase 2 primary completion: NCT07586202

A Study of Neoadjuvant Amivantamab With Either Lazertinib or Chemotherapy in Participants With Resectable EGFR-Mutated NSCLC

Primary completionMay 31, 2028· ClinicalTrials.gov

Phase 2 primary completion: NCT06116682

Targeted Treatment for Advanced Non-Small Cell Lung Cancer That Has Increased Copies of the MET Gene (An Expanded Lung-MAP Treatment Trial)

Primary completionOct 31, 2028· ClinicalTrials.gov

Phase 2 primary completion: NCT07062354

Combined Amivantamab, Carboplatin and Paclitaxel in Unresectable Locally Recurrent or Metastatic Head and Neck Cancer

Primary completionNov 30, 2028· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT07227025

A Study of Amivantamab and Olomorasib Combination Therapy in Participants With Metastatic Non-Small Cell Lung Cancer

Primary completionDec 15, 2028· ClinicalTrials.gov

Phase 3 primary completion: NCT06662786

A Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NR

Primary completionFeb 28, 2029· ClinicalTrials.gov

Phase 2 primary completion: NCT07042295

Treatment With Amivantamab and Hyaluronidase or Cetuximab for Advanced Skin Cancer in People With a Weakened Immune System

Primary completionMay 23, 2029· ClinicalTrials.gov

Phase 2 primary completion: NCT06667076

A Study of Amivantamab in Combination With Lazertinib, or Amivantamab in Combination With Platinum-Based Chemotherapy, for Common Epidermal

Primary completionJun 18, 2029· ClinicalTrials.gov

Phase 3 primary completion: NCT07276399

A Study of Amivantamab in Addition to Standard of Care Agents (SOC) Compared With SOC Alone in Participants With Recurrent/Metastatic Head a

Primary completionJan 31, 2031· ClinicalTrials.gov

Phase 2 primary completion: NCT07507188

Collaborative Clinical-translational Cohort of Amivantamab Plus Lazertinib and Amivantamab Plus Chemotherapy in Patients With EGFR-mutant, L

Primary completionDec 27, 2032· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT06385080

A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer

Past events

2026

Label revisionAug 17, 2026· FDA

Indication and usage updated on Ocrevus Zunovo label (effective 2026-08-17)

1 INDICATIONS AND USAGE OCREVUS ZUNOVO is indicated for the treatment of: Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults

Primary completionJul 31, 2026· ClinicalTrials.gov

Phase 1 primary completion: NCT06507306

A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies

Trial startedJul 28, 2026· ClinicalTrials.gov

Phase 2 trial started: NCT07586202

A Study of Neoadjuvant Amivantamab With Either Lazertinib or Chemotherapy in Participants With Resectable EGFR-Mutated NSCLC

Trial startedJul 17, 2026· ClinicalTrials.gov

Phase 2 trial started: NCT07586202

A Study of Neoadjuvant Amivantamab With Either Lazertinib or Chemotherapy in Participants With Resectable EGFR-Mutated NSCLC

Primary completionJun 9, 2026· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT05488314

A Study of Amivantamab and Capmatinib Combination Therapy in Unresectable Metastatic Non-small Cell Lung Cancer

Primary completionJun 3, 2026· ClinicalTrials.gov

Phase 1 primary completion: NCT04077463

A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer

Primary completionMay 31, 2026· ClinicalTrials.gov

Phase 2 primary completion: NCT05845450

Pre-operative Targeted Treatments in Molecularly Selected Resectable Colorectal Cancer (UNICORN)

Label revisionMay 29, 2026· FDA

Boxed warning present on label on Herceptin Hylecta label (effective 2026-05-29)

WARNING: CARDIOMYOPATHY, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY WARNING: CARDIOMYOPATHY, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY See full prescribing information for complete boxed warning. Cardiomyopathy: HERCEPTIN HYLECTA can

Primary completionMay 29, 2026· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT06532032

A Study of Combination Therapy With Amivantamab and Docetaxel in Participants With Metastatic Non-small Cell Lung Cancer

Label revisionMay 21, 2026· FDA

Boxed warning present on label on Phesgo label (effective 2026-05-21)

FDA approval (supplemental)May 18, 2026· FDA

FDA approved supplemental application for Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) — Labeling (BLA 761106 S-14)

Sponsor: GENENTECH INC. Class: Labeling.

FDA approval (supplemental)May 18, 2026· FDA

FDA approved supplemental application for Phesgo (pertuzumab, trastuzumab, and hyaluronidase-zzxf) — Labeling (BLA 761170 S-16)

Sponsor: GENENTECH INC. Class: Labeling.

FDA approval (supplemental)May 15, 2026· FDA

FDA approved supplemental application for Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) — Efficacy (BLA 761347 S-8)

Sponsor: GENENTECH INC. Class: Efficacy.

Trial registeredMay 14, 2026· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT07586202

A Study of Neoadjuvant Amivantamab With Either Lazertinib or Chemotherapy in Participants With Resectable EGFR-Mutated NSCLC

Primary completionMay 14, 2026· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT06532032

A Study of Combination Therapy With Amivantamab and Docetaxel in Participants With Metastatic Non-small Cell Lung Cancer

FDA approval (supplemental)May 12, 2026· FDA

FDA approved supplemental application for Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) — Labeling (BLA 761381 S-12)

Sponsor: BRISTOL-MYERS SQUIBB. Class: Labeling.

FDA approval (supplemental)May 12, 2026· FDA

FDA approved supplemental application for Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) — Labeling (BLA 761347 S-9)

Sponsor: GENENTECH INC. Class: Labeling.

Results postedMay 8, 2026· ClinicalTrials.gov

Trial results posted: NCT05074940

Amivantamab in Adenoid Cystic Carcinoma

FDA approval (supplemental)May 8, 2026· FDA

FDA approved supplemental application for Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase (human recombinant)) — Efficacy (BLA 761304 S-18)

Sponsor: ARGENX BV. Class: Efficacy.

Primary completionApr 14, 2026· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT06532032

A Study of Combination Therapy With Amivantamab and Docetaxel in Participants With Metastatic Non-small Cell Lung Cancer

Trial startedApr 6, 2026· ClinicalTrials.gov

Phase 2 trial started: NCT07507188

Collaborative Clinical-translational Cohort of Amivantamab Plus Lazertinib and Amivantamab Plus Chemotherapy in Patients With EGFR-mutant, L

Trial registeredApr 2, 2026· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT07507188

Collaborative Clinical-translational Cohort of Amivantamab Plus Lazertinib and Amivantamab Plus Chemotherapy in Patients With EGFR-mutant, L

Trial startedMar 25, 2026· ClinicalTrials.gov

Phase 2 trial started: NCT07062354

Combined Amivantamab, Carboplatin and Paclitaxel in Unresectable Locally Recurrent or Metastatic Head and Neck Cancer

Trial startedMar 23, 2026· ClinicalTrials.gov

Phase 2 trial started: NCT07042295

Treatment With Amivantamab and Hyaluronidase or Cetuximab for Advanced Skin Cancer in People With a Weakened Immune System

Primary completionMar 5, 2026· ClinicalTrials.gov

Phase 1 primary completion: NCT06632236

5G-EMERALD: Amivantamab in Malignant Brain Tumours

Trial startedMar 3, 2026· ClinicalTrials.gov

Phase 1/Phase 2 trial started: NCT07227025

A Study of Amivantamab and Olomorasib Combination Therapy in Participants With Metastatic Non-Small Cell Lung Cancer

Primary completionMar 2, 2026· ClinicalTrials.gov

Phase 2 primary completion: NCT05074940

Amivantamab in Adenoid Cystic Carcinoma

FDA approval (supplemental)Feb 26, 2026· FDA

FDA approved supplemental application for Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase (human recombinant)) — Labeling (BLA 761304 S-19)

Sponsor: ARGENX BV. Class: Labeling.

FDA approvalFeb 13, 2026· FDA

FDA approved Rybrevant Faspro (amivantamab and hyaluronidase-lpuj (human recombinant)) (BLA 761484)

Sponsor: JANSSEN BIOTECH. Class: Type 5 - New Formulation or New Manufacturer.

FDA approval (supplemental)Feb 12, 2026· FDA

FDA approved supplemental application for Darzalex Faspro (daratumumab and hyaluronidase-fihj (human recombinant)) — Labeling (BLA 761145 S-39)

Sponsor: JANSSEN BIOTECH. Class: Labeling.

Trial registeredFeb 6, 2026· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT07392658

Phase II Trial of Amivantamab Plus Monochemotherapy in Platinum Unfit NSCLC Patients With EGFR exon20 Insertion Mutations.

Results postedFeb 2, 2026· ClinicalTrials.gov

Trial results posted: NCT05388669

A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Recep

Primary completionJan 30, 2026· ClinicalTrials.gov

Phase 2 primary completion: NCT05299125

Amivantamab, Lazertinib, and Pemetrexed for First-line Treatment of Recurrent/Metastatic Non-small Cell Lung Cancers With Epidermal Growth F

FDA approval (supplemental)Jan 27, 2026· FDA

FDA approved supplemental application for Darzalex Faspro (daratumumab and hyaluronidase-fihj (human recombinant)) — Efficacy (BLA 761145 S-28)

Sponsor: JANSSEN BIOTECH. Class: Efficacy.

2025

FDA approvalDec 17, 2025· FDA

FDA approved Rybrevant Faspro (amivantamab and hyaluronidase-lpuj (human recombinant)) (BLA 761433)

Sponsor: JANSSEN BIOTECH. Class: Type 5 - New Formulation or New Manufacturer.

Primary completionDec 15, 2025· ClinicalTrials.gov

Phase 2 primary completion: NCT04965090

A Study of Amivantamab and Lazertinib in People With Non-Small Cell Lung Cancer (NSCLC)

Trial registeredDec 11, 2025· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT07276399

A Study of Amivantamab in Addition to Standard of Care Agents (SOC) Compared With SOC Alone in Participants With Recurrent/Metastatic Head a

Trial startedDec 3, 2025· ClinicalTrials.gov

Phase 3 trial started: NCT07276399

A Study of Amivantamab in Addition to Standard of Care Agents (SOC) Compared With SOC Alone in Participants With Recurrent/Metastatic Head a

Trial startedDec 2, 2025· ClinicalTrials.gov

Phase 2 trial started: NCT07392658

Phase II Trial of Amivantamab Plus Monochemotherapy in Platinum Unfit NSCLC Patients With EGFR exon20 Insertion Mutations.

FDA approval (supplemental)Nov 24, 2025· FDA

FDA approved supplemental application for Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) — Efficacy (BLA 761381 S-5)

Sponsor: BRISTOL-MYERS SQUIBB. Class: Efficacy.

FDA approval (supplemental)Nov 24, 2025· FDA

FDA approved supplemental application for Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) — Efficacy (BLA 761347 S-4)

Sponsor: GENENTECH INC. Class: Efficacy.

FDA approval (supplemental)Nov 19, 2025· FDA

FDA approved supplemental application for Darzalex Faspro (daratumumab and hyaluronidase-fihj (human recombinant)) — Efficacy (BLA 761145 S-32)

Sponsor: JANSSEN BIOTECH. Class: Efficacy.

FDA approval (supplemental)Nov 17, 2025· FDA

FDA approved supplemental application for Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) — Labeling (BLA 761347 S-5)

Sponsor: GENENTECH INC. Class: Labeling.

FDA approval (supplemental)Nov 14, 2025· FDA

FDA approved supplemental application for Darzalex Faspro (daratumumab and hyaluronidase-fihj (human recombinant)) — Labeling (BLA 761145 S-35)

Sponsor: JANSSEN BIOTECH. Class: Labeling.

Trial registeredNov 12, 2025· ClinicalTrials.gov

Phase 1/Phase 2 trial registered on ClinicalTrials.gov: NCT07227025

A Study of Amivantamab and Olomorasib Combination Therapy in Participants With Metastatic Non-Small Cell Lung Cancer

Label revisionNov 11, 2025· FDA

Indication and usage updated on Rybrevant label (effective 2025-11-11)

1 INDICATIONS AND USAGE RYBREVANT is a bispecific EGF receptor-directed and MET receptor-directed antibody indicated: in combination with lazertinib for the first-line treatment of adult patients with locally advanced or metastatic non-smal

FDA approval (supplemental)Nov 7, 2025· FDA

FDA approved supplemental application for Rybrevant (amivantamab-vmjw) — Labeling (BLA 761210 S-11)

Sponsor: JANSSEN BIOTECH. Class: Labeling.

FDA approval (supplemental)Nov 6, 2025· FDA

FDA approved supplemental application for Darzalex Faspro (daratumumab and hyaluronidase-fihj (human recombinant)) — Efficacy (BLA 761145 S-29)

Sponsor: JANSSEN BIOTECH. Class: Efficacy.

FDA approval (supplemental)Oct 27, 2025· FDA

FDA approved supplemental application for Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) — Efficacy (BLA 761381 S-1)

Sponsor: BRISTOL-MYERS SQUIBB. Class: Efficacy.

FDA approval (supplemental)Oct 27, 2025· FDA

FDA approved supplemental application for Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) — Efficacy (BLA 761381 S-2)

Sponsor: BRISTOL-MYERS SQUIBB. Class: Efficacy.

Results postedOct 20, 2025· ClinicalTrials.gov

Trial results posted: NCT05663866

Premedication to Reduce Amivantamab Associated Infusion Related Reactions

FDA approval (supplemental)Oct 17, 2025· FDA

FDA approved supplemental application for Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase (human recombinant)) — Efficacy (BLA 761304 S-10)

Sponsor: ARGENX BV. Class: Efficacy.

FDA approval (supplemental)Oct 8, 2025· FDA

FDA approved supplemental application for Rybrevant (amivantamab-vmjw) — Labeling (BLA 761210 S-10)

Sponsor: JANSSEN BIOTECH. Class: Labeling.

FDA approval (supplemental)Oct 2, 2025· FDA

FDA approved supplemental application for Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) — Efficacy (BLA 761347 S-3)

Sponsor: GENENTECH INC. Class: Efficacy.

FDA approval (supplemental)Sep 3, 2025· FDA

FDA approved supplemental application for Rybrevant (amivantamab-vmjw) — Labeling (BLA 761210 S-8)

Sponsor: JANSSEN BIOTECH. Class: Labeling.

FDA approval (supplemental)Aug 18, 2025· FDA

FDA approved supplemental application for Ocrevus Zunovo (ocrelizumab and hyaluronidase) — Labeling (BLA 761371 S-1)

Sponsor: GENENTECH INC. Class: Labeling.

FDA approval (supplemental)Aug 18, 2025· FDA

FDA approved supplemental application for Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) — Labeling (BLA 761347 S-2)

Sponsor: GENENTECH INC. Class: Labeling.

FDA approval (supplemental)Aug 14, 2025· FDA

FDA approved supplemental application for Rybrevant (amivantamab-vmjw) — Efficacy (BLA 761210 S-9)

Sponsor: JANSSEN BIOTECH. Class: Efficacy.

Primary completionAug 5, 2025· ClinicalTrials.gov

Phase 2 primary completion: NCT05074940

Amivantamab in Adenoid Cystic Carcinoma

Trial registeredJul 14, 2025· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT07062354

Combined Amivantamab, Carboplatin and Paclitaxel in Unresectable Locally Recurrent or Metastatic Head and Neck Cancer

Trial registeredJun 29, 2025· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT07042295

Treatment With Amivantamab and Hyaluronidase or Cetuximab for Advanced Skin Cancer in People With a Weakened Immune System

Primary completionMay 31, 2025· ClinicalTrials.gov

Phase 2 primary completion: NCT03767075

A Modular Multi-Basket Trial to Improve Personalized Medicine in Cancer Patients (Basket of Baskets)

Trial startedMay 31, 2025· ClinicalTrials.gov

Phase 2 trial started: NCT06855849

An Open-label, Single-arm, Multicenter Phase II Study to Evaluate the Efficacy of Amivantamab in Combination With FOLFIRI as a Second-line T

FDA approval (supplemental)May 23, 2025· FDA

FDA approved supplemental application for Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) — Labeling (BLA 761381 S-8)

Sponsor: BRISTOL-MYERS SQUIBB. Class: Labeling.

Results postedApr 16, 2025· ClinicalTrials.gov

Trial results posted: NCT04988295

A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients

FDA approval (supplemental)Apr 10, 2025· FDA

FDA approved supplemental application for Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase (human recombinant)) — Efficacy (BLA 761304 S-8)

Sponsor: ARGENX BV. Class: Efficacy.

Trial registeredMar 4, 2025· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06855849

An Open-label, Single-arm, Multicenter Phase II Study to Evaluate the Efficacy of Amivantamab in Combination With FOLFIRI as a Second-line T

Trial startedFeb 27, 2025· ClinicalTrials.gov

Phase 1 trial started: NCT06816992

ORIC-114 in Combination With Subcutaneous Amivantamab in Patients With EGFR Exon20 Insertion Mutant NSCLC

FDA approval (supplemental)Feb 14, 2025· FDA

FDA approved supplemental application for Rybrevant (amivantamab-vmjw) — Labeling (BLA 761210 S-7)

Sponsor: JANSSEN BIOTECH. Class: Labeling.

Trial registeredFeb 10, 2025· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT06816992

ORIC-114 in Combination With Subcutaneous Amivantamab in Patients With EGFR Exon20 Insertion Mutant NSCLC

Trial registeredJan 20, 2025· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06784791

Preoperative Amivantamab or Amivantamab and Carboplatin/Pemetrexed Treatment in Patients With Resectable Non-small-cell Lung Cancer Harborin

2024

Trial registeredDec 27, 2024· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06750094

A Study of Amivantamab and FOLFIRI Versus Cetuximab/Bevacizumab and FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Colorectal Can

FDA approvalDec 27, 2024· FDA

FDA approved Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) (BLA 761381)

Sponsor: BRISTOL-MYERS SQUIBB. Class: Type 3 - New Dosage Form.

Trial startedDec 16, 2024· ClinicalTrials.gov

Phase 2 trial started: NCT06667076

A Study of Amivantamab in Combination With Lazertinib, or Amivantamab in Combination With Platinum-Based Chemotherapy, for Common Epidermal

Trial startedDec 12, 2024· ClinicalTrials.gov

Phase 3 trial started: NCT06750094

A Study of Amivantamab and FOLFIRI Versus Cetuximab/Bevacizumab and FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Colorectal Can

FDA approval (supplemental)Nov 22, 2024· FDA

FDA approved supplemental application for Phesgo (pertuzumab, trastuzumab, and hyaluronidase-zzxf) — Efficacy (BLA 761170 S-7)

Sponsor: GENENTECH INC. Class: Efficacy.

Trial startedNov 19, 2024· ClinicalTrials.gov

Phase 2 trial started: NCT06116682

Targeted Treatment for Advanced Non-Small Cell Lung Cancer That Has Increased Copies of the MET Gene (An Expanded Lung-MAP Treatment Trial)

Trial startedNov 6, 2024· ClinicalTrials.gov

Phase 2 trial started: NCT06784791

Preoperative Amivantamab or Amivantamab and Carboplatin/Pemetrexed Treatment in Patients With Resectable Non-small-cell Lung Cancer Harborin

Trial registeredOct 31, 2024· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06667076

A Study of Amivantamab in Combination With Lazertinib, or Amivantamab in Combination With Platinum-Based Chemotherapy, for Common Epidermal

Results postedOct 30, 2024· ClinicalTrials.gov

Trial results posted: NCT05653427

A Study of Amivantamab Monotherapy in Participants With Previously Treated Advanced Hepatocellular Carcinoma

Trial registeredOct 29, 2024· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06662786

A Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NR

Trial startedOct 18, 2024· ClinicalTrials.gov

Phase 3 trial started: NCT06662786

A Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NR

Results postedOct 9, 2024· ClinicalTrials.gov

Trial results posted: NCT04487080

A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Trial registeredOct 9, 2024· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT06632236

5G-EMERALD: Amivantamab in Malignant Brain Tumours

Trial startedOct 9, 2024· ClinicalTrials.gov

Phase 1 trial started: NCT06632236

5G-EMERALD: Amivantamab in Malignant Brain Tumours

Results postedSep 19, 2024· ClinicalTrials.gov

Trial results posted: NCT04945733

A Study of Amivantamab in Participants With Previously Treated Advanced or Metastatic Gastric or Esophageal Cancer

FDA approval (supplemental)Sep 19, 2024· FDA

FDA approved supplemental application for Rybrevant (amivantamab-vmjw) — Efficacy (BLA 761210 S-4)

Sponsor: JANSSEN BIOTECH. Class: Efficacy.

FDA approvalSep 13, 2024· FDA

FDA approved Ocrevus Zunovo (ocrelizumab and hyaluronidase) (BLA 761371)

Sponsor: GENENTECH INC. Class: Type 3 - New Dosage Form.

FDA approvalSep 12, 2024· FDA

FDA approved Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) (BLA 761347)

Sponsor: GENENTECH INC. Class: Type 3 - New Dosage Form.

RecallSep 11, 2024· FDA

HYLENEX RECOMBINANT recall — Class II: cGMP Deviations: Temperature excursion

Hylenex recombinant (hyaluronidase) injection, 150 USP units/mL, 4x1 mL Single Dose Vials, Rx only, Manufactured for and marketed by Halozyme, Inc., 12390 El Camino Real San Diego California 92130, Distributed by Antares Pharma, Inc., Ewing

Primary completionAug 24, 2024· ClinicalTrials.gov

Phase 2 primary completion: NCT05601973

Amivantamab, Lazertinib and Bevacizumab in Patients With EGFR-mutant Advanced Non-small Cell Lung Cancer With Progression on Previous Third-

FDA approval (supplemental)Aug 19, 2024· FDA

FDA approved supplemental application for Rybrevant (amivantamab-vmjw) — Efficacy (BLA 761210 S-5)

Sponsor: JANSSEN BIOTECH. Class: Efficacy.

Primary completionAug 19, 2024· ClinicalTrials.gov

Phase 2 primary completion: NCT05299125

Amivantamab, Lazertinib, and Pemetrexed for First-line Treatment of Recurrent/Metastatic Non-small Cell Lung Cancers With Epidermal Growth F

FDA approval (supplemental)Aug 8, 2024· FDA

FDA approved supplemental application for Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase (human recombinant)) — Efficacy (BLA 761304 S-3)

Sponsor: ARGENX BV. Class: Efficacy.

Trial registeredAug 1, 2024· ClinicalTrials.gov

Phase 1/Phase 2 trial registered on ClinicalTrials.gov: NCT06532032

A Study of Combination Therapy With Amivantamab and Docetaxel in Participants With Metastatic Non-small Cell Lung Cancer

FDA approval (supplemental)Jul 30, 2024· FDA

FDA approved supplemental application for Darzalex Faspro (daratumumab and hyaluronidase-fihj (human recombinant)) — Efficacy (BLA 761145 S-25)

Sponsor: JANSSEN BIOTECH. Class: Efficacy.

Trial startedJul 23, 2024· ClinicalTrials.gov

Phase 1/Phase 2 trial started: NCT06532032

A Study of Combination Therapy With Amivantamab and Docetaxel in Participants With Metastatic Non-small Cell Lung Cancer

Trial registeredJul 18, 2024· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT06507306

A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies

FDA approval (supplemental)Jun 21, 2024· FDA

FDA approved supplemental application for Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase (human recombinant)) — Efficacy (BLA 761304 S-5)

Sponsor: ARGENX BV. Class: Efficacy.

FDA approval (supplemental)Jun 21, 2024· FDA

FDA approved supplemental application for Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase (human recombinant)) — Labeling (BLA 761304 S-6)

Sponsor: ARGENX BV. Class: Labeling.

FDA approval (supplemental)Jun 18, 2024· FDA

FDA approved supplemental application for Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) — Efficacy (BLA 761106 S-10)

Sponsor: GENENTECH INC. Class: Efficacy.

Trial startedJun 18, 2024· ClinicalTrials.gov

Phase 1/Phase 2 trial started: NCT06083857

PhI/II Study of Amivantamab and Tepotinib Combo in MET-altered Non-small Cell Lung Cancer

Trial startedJun 3, 2024· ClinicalTrials.gov

Phase 1 trial started: NCT06507306

A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies

Results postedMay 29, 2024· ClinicalTrials.gov

Trial results posted: NCT04538664

A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced o

Trial registeredApr 25, 2024· ClinicalTrials.gov

Phase 1/Phase 2 trial registered on ClinicalTrials.gov: NCT06385080

A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer

Trial startedApr 22, 2024· ClinicalTrials.gov

Phase 1/Phase 2 trial started: NCT06385080

A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer

Primary completionMar 29, 2024· ClinicalTrials.gov

Phase 2 primary completion: NCT05663866

Premedication to Reduce Amivantamab Associated Infusion Related Reactions

FDA approval (supplemental)Mar 1, 2024· FDA

FDA approved supplemental application for Rybrevant (amivantamab-vmjw) — Efficacy (BLA 761210 S-3)

Sponsor: JANSSEN BIOTECH. Class: Efficacy.

Trial startedFeb 16, 2024· ClinicalTrials.gov

Phase 2 trial started: NCT06120140

Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NS

FDA approval (supplemental)Jan 12, 2024· FDA

FDA approved supplemental application for Hylenex Recombinant (hyaluronidase) — Labeling (BLA 021859 S-31)

Sponsor: HALOZYME THERAP. Class: Labeling.

Primary completionJan 3, 2024· ClinicalTrials.gov

Phase 3 primary completion: NCT05388669

A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Recep

2023

FDA approval (supplemental)Dec 12, 2023· FDA

FDA approved supplemental application for Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase (human recombinant)) — Labeling (BLA 761304 S-2)

Sponsor: ARGENX BV. Class: Labeling.

Trial registeredNov 7, 2023· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06120140

Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NS

Trial registeredNov 3, 2023· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06116682

Targeted Treatment for Advanced Non-Small Cell Lung Cancer That Has Increased Copies of the MET Gene (An Expanded Lung-MAP Treatment Trial)

Trial registeredOct 16, 2023· ClinicalTrials.gov

Phase 1/Phase 2 trial registered on ClinicalTrials.gov: NCT06083857

PhI/II Study of Amivantamab and Tepotinib Combo in MET-altered Non-small Cell Lung Cancer

Primary completionOct 10, 2023· ClinicalTrials.gov

Phase 2 primary completion: NCT05653427

A Study of Amivantamab Monotherapy in Participants With Previously Treated Advanced Hepatocellular Carcinoma

Primary completionAug 11, 2023· ClinicalTrials.gov

Phase 1 primary completion: NCT05395052

FT536 Monotherapy and in Combination With Monoclonal Antibodies in Advanced Solid Tumors

Primary completionAug 11, 2023· ClinicalTrials.gov

Phase 3 primary completion: NCT04487080

A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Trial startedJul 18, 2023· ClinicalTrials.gov

Phase 2 trial started: NCT05801029

A Study to Investigate Safety and Efficacy of Osimertinib and Amivantamab in Participants With Non-small Cell Lung Cancer With Common Epider

Trial startedJul 17, 2023· ClinicalTrials.gov

Phase 1/Phase 2 trial started: NCT05845671

Amivantamab With Tyrosine Kinase Inhibitors (TKI) for Advanced NSCLC With ALK, ROS1, or RET Alterations

Primary completionJul 10, 2023· ClinicalTrials.gov

Phase 3 primary completion: NCT04988295

A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients

Primary completionJul 3, 2023· ClinicalTrials.gov

Phase 2 primary completion: NCT04945733

A Study of Amivantamab in Participants With Previously Treated Advanced or Metastatic Gastric or Esophageal Cancer

FDA approvalJun 20, 2023· FDA

FDA approved Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase (human recombinant)) (BLA 761304)

Sponsor: ARGENX BV.

Trial registeredJun 18, 2023· ClinicalTrials.gov

Phase 1/Phase 2 trial registered on ClinicalTrials.gov: NCT05908734

A Study of Combination Therapy With Amivantamab and Cetrelimab in Participants With Metastatic Non-small Cell Lung Cancer

Trial startedMay 24, 2023· ClinicalTrials.gov

Phase 2 trial started: NCT05299125

Amivantamab, Lazertinib, and Pemetrexed for First-line Treatment of Recurrent/Metastatic Non-small Cell Lung Cancers With Epidermal Growth F

Trial startedMay 18, 2023· ClinicalTrials.gov

Phase 1/Phase 2 trial started: NCT05908734

A Study of Combination Therapy With Amivantamab and Cetrelimab in Participants With Metastatic Non-small Cell Lung Cancer

Trial startedMay 18, 2023· ClinicalTrials.gov

Phase 2 trial started: NCT05663866

Premedication to Reduce Amivantamab Associated Infusion Related Reactions

Trial startedMay 11, 2023· ClinicalTrials.gov

Phase 2 trial started: NCT05845450

Pre-operative Targeted Treatments in Molecularly Selected Resectable Colorectal Cancer (UNICORN)

Trial registeredMay 6, 2023· ClinicalTrials.gov

Phase 1/Phase 2 trial registered on ClinicalTrials.gov: NCT05845671

Amivantamab With Tyrosine Kinase Inhibitors (TKI) for Advanced NSCLC With ALK, ROS1, or RET Alterations

Trial registeredMay 6, 2023· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05845450

Pre-operative Targeted Treatments in Molecularly Selected Resectable Colorectal Cancer (UNICORN)

Primary completionMay 3, 2023· ClinicalTrials.gov

Phase 3 primary completion: NCT04538664

A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced o

Trial registeredApr 6, 2023· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05801029

A Study to Investigate Safety and Efficacy of Osimertinib and Amivantamab in Participants With Non-small Cell Lung Cancer With Common Epider

Trial startedMar 27, 2023· ClinicalTrials.gov

Phase 2 trial started: NCT05601973

Amivantamab, Lazertinib and Bevacizumab in Patients With EGFR-mutant Advanced Non-small Cell Lung Cancer With Progression on Previous Third-

2022

Trial registeredDec 23, 2022· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05663866

Premedication to Reduce Amivantamab Associated Infusion Related Reactions

Trial registeredDec 16, 2022· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05653427

A Study of Amivantamab Monotherapy in Participants With Previously Treated Advanced Hepatocellular Carcinoma

Trial startedDec 13, 2022· ClinicalTrials.gov

Phase 1/Phase 2 trial started: NCT05488314

A Study of Amivantamab and Capmatinib Combination Therapy in Unresectable Metastatic Non-small Cell Lung Cancer

Trial startedDec 8, 2022· ClinicalTrials.gov

Phase 2 trial started: NCT05653427

A Study of Amivantamab Monotherapy in Participants With Previously Treated Advanced Hepatocellular Carcinoma

Trial startedNov 11, 2022· ClinicalTrials.gov

Phase 2 trial started: NCT05498428

A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated No

FDA approval (supplemental)Nov 4, 2022· FDA

FDA approved supplemental application for Rybrevant (amivantamab-vmjw) — Efficacy (BLA 761210 S-2)

Sponsor: JANSSEN BIOTECH. Class: Efficacy.

FDA approval (supplemental)Nov 2, 2022· FDA

FDA approved supplemental application for Darzalex Faspro (daratumumab and hyaluronidase-fihj (human recombinant)) — Labeling (BLA 761145 S-18)

Sponsor: JANSSEN BIOTECH. Class: Labeling.

Trial registeredNov 1, 2022· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05601973

Amivantamab, Lazertinib and Bevacizumab in Patients With EGFR-mutant Advanced Non-small Cell Lung Cancer With Progression on Previous Third-

Trial registeredAug 12, 2022· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05498428

A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated No

Trial startedAug 5, 2022· ClinicalTrials.gov

Phase 3 trial started: NCT05388669

A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Recep

Trial startedAug 5, 2022· ClinicalTrials.gov

Phase 2 trial started: NCT05074940

Amivantamab in Adenoid Cystic Carcinoma

Trial registeredAug 4, 2022· ClinicalTrials.gov

Phase 1/Phase 2 trial registered on ClinicalTrials.gov: NCT05488314

A Study of Amivantamab and Capmatinib Combination Therapy in Unresectable Metastatic Non-small Cell Lung Cancer

Trial startedJul 29, 2022· ClinicalTrials.gov

Phase 1/Phase 2 trial started: NCT05379595

A Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic Colorectal C

Trial startedMay 31, 2022· ClinicalTrials.gov

Phase 1 trial started: NCT05395052

FT536 Monotherapy and in Combination With Monoclonal Antibodies in Advanced Solid Tumors

Trial registeredMay 27, 2022· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT05395052

FT536 Monotherapy and in Combination With Monoclonal Antibodies in Advanced Solid Tumors

Trial registeredMay 24, 2022· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05388669

A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Recep

Trial registeredMay 18, 2022· ClinicalTrials.gov

Phase 1/Phase 2 trial registered on ClinicalTrials.gov: NCT05379595

A Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic Colorectal C

Trial registeredMar 28, 2022· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05299125

Amivantamab, Lazertinib, and Pemetrexed for First-line Treatment of Recurrent/Metastatic Non-small Cell Lung Cancers With Epidermal Growth F

FDA approval (supplemental)Jan 21, 2022· FDA

FDA approved supplemental application for Darzalex Faspro (daratumumab and hyaluronidase-fihj (human recombinant)) — Labeling (BLA 761145 S-12)

Sponsor: JANSSEN BIOTECH. Class: Labeling.

2021

FDA approval (supplemental)Dec 21, 2021· FDA

FDA approved supplemental application for Rybrevant (amivantamab-vmjw) — Labeling (BLA 761210 S-1)

Sponsor: JANSSEN BIOTECH. Class: Labeling.

Trial startedDec 2, 2021· ClinicalTrials.gov

Phase 2 trial started: NCT05117931

A Study of Amivantamab in People With Esophagogastric Cancer

FDA approval (supplemental)Nov 30, 2021· FDA

FDA approved supplemental application for Darzalex Faspro (daratumumab and hyaluronidase-fihj (human recombinant)) — Efficacy (BLA 761145 S-9)

Sponsor: JANSSEN BIOTECH. Class: Efficacy.

Trial startedNov 17, 2021· ClinicalTrials.gov

Phase 3 trial started: NCT04988295

A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients

Trial registeredNov 11, 2021· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05117931

A Study of Amivantamab in People With Esophagogastric Cancer

Trial registeredOct 12, 2021· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05074940

Amivantamab in Adenoid Cystic Carcinoma

Trial startedSep 30, 2021· ClinicalTrials.gov

Phase 2 trial started: NCT04965090

A Study of Amivantamab and Lazertinib in People With Non-Small Cell Lung Cancer (NSCLC)

Trial startedAug 30, 2021· ClinicalTrials.gov

Phase 2 trial started: NCT04945733

A Study of Amivantamab in Participants With Previously Treated Advanced or Metastatic Gastric or Esophageal Cancer

Trial registeredAug 3, 2021· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT04988295

A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients

Trial registeredJul 16, 2021· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT04965090

A Study of Amivantamab and Lazertinib in People With Non-Small Cell Lung Cancer (NSCLC)

FDA approval (supplemental)Jul 9, 2021· FDA

FDA approved supplemental application for Darzalex Faspro (daratumumab and hyaluronidase-fihj (human recombinant)) — Efficacy (BLA 761145 S-7)

Sponsor: JANSSEN BIOTECH. Class: Efficacy.

Trial registeredJun 30, 2021· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT04945733

A Study of Amivantamab in Participants With Previously Treated Advanced or Metastatic Gastric or Esophageal Cancer

FDA approval (supplemental)Jun 10, 2021· FDA

FDA approved supplemental application for Rituxan Hycela (rituximab and hyaluronidase) — Labeling (BLA 761064 S-13)

Sponsor: GENENTECH INC. Class: Labeling.

FDA approvalMay 21, 2021· FDA

FDA approved Rybrevant (amivantamab-vmjw) (BLA 761210)

Sponsor: JANSSEN BIOTECH. Class: Type 1 - New Molecular Entity.

FDA approval (supplemental)Mar 12, 2021· FDA

FDA approved supplemental application for Darzalex Faspro (daratumumab and hyaluronidase-fihj (human recombinant)) — Labeling (BLA 761145 S-5)

Sponsor: JANSSEN BIOTECH. Class: Labeling.

FDA approval (supplemental)Feb 8, 2021· FDA

FDA approved supplemental application for Darzalex Faspro (daratumumab and hyaluronidase-fihj (human recombinant)) — Labeling (BLA 761145 S-8)

Sponsor: JANSSEN BIOTECH. Class: Labeling.

FDA approval (supplemental)Jan 15, 2021· FDA

FDA approved supplemental application for Darzalex Faspro (daratumumab and hyaluronidase-fihj (human recombinant)) — Efficacy (BLA 761145 S-2)

Sponsor: JANSSEN BIOTECH. Class: Efficacy.

FDA approval (supplemental)Jan 11, 2021· FDA

FDA approved supplemental application for Darzalex Faspro (daratumumab and hyaluronidase-fihj (human recombinant)) — Efficacy (BLA 761145 S-1)

Sponsor: JANSSEN BIOTECH. Class: Efficacy.

2020

Trial registeredOct 23, 2020· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT04599712

Pre-Approval Access With Amivantamab (JNJ-61186372) in Participants With Metastatic Non-Small Cell Lung Cancer

Trial startedOct 13, 2020· ClinicalTrials.gov

Phase 3 trial started: NCT04538664

A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced o

Trial startedSep 30, 2020· ClinicalTrials.gov

Phase 3 trial started: NCT04487080

A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Trial registeredSep 4, 2020· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT04538664

A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced o

Trial registeredJul 27, 2020· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT04487080

A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

FDA approvalJun 29, 2020· FDA

FDA approved Phesgo (pertuzumab, trastuzumab, and hyaluronidase-zzxf) (BLA 761170)

Sponsor: GENENTECH INC. Class: Type 4 - New Combination.

FDA approval (supplemental)May 5, 2020· FDA

FDA approved supplemental application for Rituxan Hycela (rituximab and hyaluronidase) — Labeling (BLA 761064 S-10)

Sponsor: GENENTECH INC. Class: Labeling.

FDA approval (supplemental)May 5, 2020· FDA

FDA approved supplemental application for Rituxan Hycela (rituximab and hyaluronidase) — Labeling (BLA 761064 S-8)

Sponsor: GENENTECH INC. Class: Labeling.

FDA approvalMay 1, 2020· FDA

FDA approved Darzalex Faspro (daratumumab and hyaluronidase-fihj (human recombinant)) (BLA 761145)

Sponsor: JANSSEN BIOTECH. Class: Type 3 - New Dosage Form and Type 4 - New Combination.

2019

FDA approval (supplemental)Dec 19, 2019· FDA

FDA approved supplemental application for Rituxan Hycela (rituximab and hyaluronidase) — Labeling (BLA 761064 S-9)

Sponsor: GENENTECH INC. Class: Labeling.

Trial registeredSep 4, 2019· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT04077463

A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer

Trial startedSep 4, 2019· ClinicalTrials.gov

Phase 1 trial started: NCT04077463

A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer

FDA approvalFeb 28, 2019· FDA

FDA approved Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) (BLA 761106)

Sponsor: GENENTECH INC. Class: Type 5 - New Formulation or New Manufacturer.

2018

Trial startedDec 10, 2018· ClinicalTrials.gov

Phase 2 trial started: NCT03767075

A Modular Multi-Basket Trial to Improve Personalized Medicine in Cancer Patients (Basket of Baskets)

Trial registeredDec 6, 2018· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT03767075

A Modular Multi-Basket Trial to Improve Personalized Medicine in Cancer Patients (Basket of Baskets)

2017

FDA approval (supplemental)Jun 22, 2017· FDA

FDA approved supplemental application for Rituxan Hycela (rituximab and hyaluronidase) — Type 5 - New Formulation or New Manufacturer (BLA 761064 S-1)

Sponsor: GENENTECH INC. Class: Type 5 - New Formulation or New Manufacturer.

FDA approvalJun 22, 2017· FDA

FDA approved Rituxan Hycela (rituximab and hyaluronidase) (BLA 761064)

Sponsor: GENENTECH INC. Class: Type 5 - New Formulation or New Manufacturer.

2016

FDA approval (supplemental)Jul 28, 2016· FDA

FDA approved supplemental application for Hylenex Recombinant (hyaluronidase) — Manufacturing (CMC) (BLA 021859 S-24)

Sponsor: HALOZYME THERAP. Class: Manufacturing (CMC).

FDA approval (supplemental)Jun 21, 2016· FDA

FDA approved supplemental application for Hylenex Recombinant (hyaluronidase) — Manufacturing (CMC) (BLA 021859 S-25)

Sponsor: HALOZYME THERAP. Class: Manufacturing (CMC).

Trial startedMay 24, 2016· ClinicalTrials.gov

Phase 1 trial started: NCT02609776

Study of Amivantamab, a Human Bispecific EGFR and cMet Antibody, in Participants With Advanced Non-Small Cell Lung Cancer

FDA approval (supplemental)Jan 21, 2016· FDA

FDA approved supplemental application for Hylenex Recombinant (hyaluronidase) — Labeling (BLA 021859 S-23)

Sponsor: HALOZYME THERAP. Class: Labeling.

2015

Trial registeredNov 20, 2015· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT02609776

Study of Amivantamab, a Human Bispecific EGFR and cMet Antibody, in Participants With Advanced Non-Small Cell Lung Cancer

FDA approval (supplemental)Jul 27, 2015· FDA

FDA approved supplemental application for Hylenex Recombinant (hyaluronidase) — Manufacturing (CMC) (BLA 021859 S-22)

Sponsor: HALOZYME THERAP. Class: Manufacturing (CMC).

FDA approval (supplemental)Apr 17, 2015· FDA

FDA approved supplemental application for Hylenex Recombinant (hyaluronidase) — Manufacturing (CMC) (BLA 021859 S-21)

Sponsor: HALOZYME THERAP. Class: Manufacturing (CMC).

2014

FDA approval (supplemental)Oct 16, 2014· FDA

FDA approved supplemental application for Hylenex Recombinant (hyaluronidase) — Manufacturing (CMC) (BLA 021859 S-19)

Sponsor: HALOZYME THERAP. Class: Manufacturing (CMC).

FDA approval (supplemental)May 6, 2014· FDA

FDA approved supplemental application for Hylenex Recombinant (hyaluronidase) — Manufacturing (CMC) (BLA 021859 S-20)

Sponsor: HALOZYME THERAP. Class: Manufacturing (CMC).

2013

FDA approval (supplemental)Jul 23, 2013· FDA

FDA approved supplemental application for Hylenex Recombinant (hyaluronidase) — Manufacturing (CMC) (BLA 021859 S-18)

Sponsor: HALOZYME THERAP. Class: Manufacturing (CMC).

2012

FDA approval (supplemental)Mar 20, 2012· FDA

FDA approved supplemental application for Hylenex Recombinant (hyaluronidase) — Labeling (BLA 021859 S-15)

Sponsor: HALOZYME THERAP. Class: Labeling.

FDA approval (supplemental)Mar 1, 2012· FDA

FDA approved supplemental application for Hylenex Recombinant (hyaluronidase) — Labeling (BLA 021859 S-9)

Sponsor: HALOZYME THERAP. Class: Labeling.

2011

Results postedNov 23, 2011· ClinicalTrials.gov

Trial results posted: NCT00477152

Study of Subcutaneous Rehydration With Recombinant Human Hyaluronidase for Infants and Children

Sources

FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.