On February 16, 2024, the FDA approved a supplemental application for Tagrisso (osimertinib), categorized in the supplied record as an efficacy action. The record identifies AstraZeneca as the sponsor but does not state what indication, population, or labeling language the application addressed.
Background
The supplied information identifies osimertinib, also known by the brand name Tagrisso, and records an FDA supplemental-application approval. It does not provide the drug’s class, mechanism, approved uses, prior approval history, or information about the condition addressed by this application. Accordingly, this record alone cannot establish whether the action added a new indication, changed an existing indication, or concerned another efficacy-related matter.
What this means
The FDA record documents an approval event, not the supporting clinical evidence or the precise scope of the decision. The supplied data contain no trial identifier, study design, patient population, comparator, endpoint, outcome measurements, safety findings, or statistical analyses. They therefore do not support a conclusion about the size or direction of any treatment benefit, or about how osimertinib performed relative to another therapy.
Clinicians and researchers seeking to determine the practical effect of the approval will need the application materials or labeling associated with the FDA record. In particular, the available entry does not identify a specific new population or claim that the product label changed. The event should be described narrowly as approval of a supplemental application classified as efficacy, without inferring an indication or clinical result absent from the supplied information.
Source
Source: U.S. Food and Drug Administration (FDA), Drug Approval Database application overview for NDA 208065, supplemental application S-30; event dated February 16, 2024. Available at accessdata.fda.gov.