The FDA approved a supplemental application for Tagrisso (osimertinib) on January 31, 2024, according to the agency’s record for NDA 208065. The record classifies the supplement as an efficacy application, but the supplied information does not state what indication, population, or use was covered.
Background
Osimertinib is also known by the brand name Tagrisso. The supplied record identifies the drug and the application sponsor, AstraZeneca, but does not provide the drug’s class, mechanism, approved uses before this action, or details about the condition addressed by the supplement. It therefore does not support a more specific account of the clinical context for the FDA action.
What this means
The event establishes that the FDA approved a supplemental application categorized as efficacy for osimertinib. The record provided here does not describe the evidence reviewed, the indication or patient group involved, or any changes to the drug’s labeling. Without those details, the approval cannot be characterized as expanding treatment to a particular disease or population, and no conclusions about the magnitude of clinical benefit can be drawn from this entry alone.
The application identifier is NDA 208065, supplement 29. The supplied data contain no trial identifier, enrollment, comparator, outcome measurements, or statistical analyses. Those details should not be inferred from the approval event or its efficacy classification.
Source
Source: FDA, Drug Approval Package database entry for Tagrisso (osimertinib), NDA 208065, supplemental application 29; event date January 31, 2024. Available at accessdata.fda.gov.