On May 23, 2020, the FDA approved a supplemental application for Tagrisso (osimertinib), according to the supplied agency record. The application was identified as NDA 208065, supplement 16, and classified as an efficacy supplement; the record does not state a new indication or provide efficacy measurements.
Background
The drug named in the FDA record is osimertinib, also known by the brand name Tagrisso. The record identifies the application as an efficacy supplement and names AstraZeneca as the sponsor. It does not describe the drug’s class or mechanism, the condition addressed by this supplement, or any prior approvals. Those details cannot be established from the supplied information.
The approval classification indicates that the agency event concerned an efficacy supplement, but the supplied record does not summarize the evidence reviewed or explain what specific change the supplemental application sought. It therefore does not support a claim that the FDA approved osimertinib for a particular disease, patient group, or use. Nor does the record provide trial design details, patient enrollment, treatment comparisons, outcome measures, or safety findings.
What this means
The record documents an FDA approval event for a supplemental Tagrisso application and identifies its supplement number and efficacy classification. It does not provide enough information to characterize the clinical evidence or determine the practical scope of the approval. Clinicians, researchers, and patient advocates seeking the specific indication or supporting data would need to consult the underlying FDA application materials; the supplied record alone does not establish those details.
Source
Source: FDA, Drug Approvals and Databases application overview for NDA 208065, covering the supplemental application identified as S-16. The supplied event date is May 23, 2020. Available at accessdata.fda.gov.