On September 14, 2026, the FDA approved a supplemental application for Tagrisso (osimertinib). The FDA record classifies the supplement as related to efficacy, but the supplied information does not identify a new indication or describe supporting clinical results.
Background
The event concerns Tagrisso, also known by its generic name, osimertinib. The supplied record identifies ASTRAZENECA as the sponsor and labels the application category “Efficacy.” It does not provide information about the drug’s mechanism, therapeutic indication, prior approvals, or the condition addressed by this supplement.
What this means
The record confirms that the FDA approved a supplemental application, but it does not explain what efficacy evidence was reviewed or what changed for patients or clinicians. In particular, it does not state whether the action added or revised an indication, identify a patient population, or report trial outcomes. Those details should not be inferred from the approval event alone; readers seeking the scope of the action would need to consult the FDA application record and any associated documents.
Source
Source: U.S. Food and Drug Administration, Drugs@FDA application overview for NDA 208065, concerning supplemental application S-35; event date September 14, 2026. Available at accessdata.fda.gov.