On December 9, 2020, the FDA approved a supplemental application for Tagrisso (osimertinib), classified in the agency record as an efficacy application. The supplied record does not identify a new indication, patient population, or clinical outcome associated with the approval.
Background
The FDA record identifies the drug as Tagrisso, with osimertinib as its generic name. It classifies the supplemental application as “Efficacy” and names AstraZeneca as the sponsor. The data supplied for this event do not describe the drug’s mechanism, the condition being treated, prior approvals, or disease prevalence, so those details cannot be established from this record.
What this means
The event confirms FDA approval of a supplemental application for osimertinib on December 9, 2020, but the available entry does not explain what efficacy evidence the agency reviewed or what specific labeling or clinical-use change followed. It provides no trial results, patient numbers, comparator, effect estimate, safety findings, or other outcome measurements. The approval should therefore not be characterized from this record as a specific new indication or as evidence of a particular treatment benefit.
The application is identified as NDA 208065, supplement 18. That identifier links the event to an FDA application record; it does not, on its own, provide the missing indication or the supporting efficacy findings. Readers seeking those details should consult the FDA record and any linked review or labeling documents.
Source
Source: U.S. Food and Drug Administration (FDA), Drug Approval Package application overview for NDA 208065, dated December 9, 2020 in the supplied event data. Available at accessdata.fda.gov.