The FDA approved a supplemental application for Tagrisso (osimertinib) on September 25, 2024. The agency’s record classifies the application as an efficacy submission, but the supplied information does not identify the specific indication, population, or evidence supporting the decision.
Background
Osimertinib is also known by the brand name Tagrisso. The FDA record identifies AstraZeneca as the sponsor and classifies the supplemental application as “Efficacy.” The information provided for this event does not describe the drug’s mechanism, its existing indications, or the condition addressed by this application. It also does not include details about prior approvals, so those matters cannot be established from this record alone.
The event is listed as an FDA approval of a supplemental application, rather than as an initial approval. However, the available entry does not state what change to the drug’s approved use the supplement sought or what patient group it concerned. It therefore does not support a more specific description of the approval’s clinical scope.
What this means
The record confirms that FDA approved an efficacy-class supplemental application for osimertinib on the stated date. It does not provide a new indication, trial results, efficacy measurements, safety findings, or a comparison with another treatment. Clinicians, researchers, and patient advocates seeking to understand how the approval may affect treatment decisions will need the underlying FDA documents or labeling for details not included in this event entry. The approval should not be interpreted from this summary as evidence of a particular benefit, patient eligibility, or change in prescribing guidance.
Source
Source: U.S. Food and Drug Administration (FDA), Drugs@FDA application overview for NDA 208065, including the supplemental application identified as S-33. The event date is September 25, 2024. Available at accessdata.fda.gov.