The FDA-listed drug record recorded an indication-and-usage revision for the Darzalex Faspro label effective September 3, 2026. The supplied data identify the drug as amivantamab, while the headline and label summary refer to Darzalex Faspro. The available summary states that Darzalex Faspro is indicated for treatment of adult patients, but the supplied text ends during the indication description.
Background
The record lists amivantamab under the aliases Rybrevant, Rybrevant Faspro, and amivantamab-vmjw. It also lists the combination name amivantamab and hyaluronidase-lpuj, along with hyaluronidase. However, the supplied label headline identifies the revised product as Darzalex Faspro. The label summary describes Darzalex Faspro as a combination of daratumumab and hyaluronidase.
In the supplied description, daratumumab is characterized as a CD38-directed cytolytic antibody, and hyaluronidase is characterized as an endoglycosidase. The indication summary begins with treatment of adult patients with multiple myeloma in combination with bor…, but the provided record does not include the remainder of that text.
What this means
The event represents a recorded FDA label revision affecting the indication-and-usage section, with an effective date of September 3, 2026. The available data do not specify the exact wording added or removed, the complete patient population, dosing instructions, safety changes, contraindications, or clinical-study results. They also do not provide trial outcomes, comparative measurements, or adverse-event analyses.
Because the supplied drug field names amivantamab while the headline and label summary name Darzalex Faspro, readers should verify the product identity and complete revised indication directly in the source label before using this record for prescribing, research, or reference editing.
Source
Source: FDA, DailyMed drug-label record for Darzalex Faspro, with the indication-and-usage revision effective September 3, 2026. Available at dailymed.nlm.nih.gov.