On March 30, 2017, the FDA approved a supplemental application for Tagrisso (osimertinib), classified in the supplied record as an efficacy action. The record identifies the application as NDA 208065, supplement 6, but does not state the specific efficacy finding or describe a new indication.
Background
The supplied information identifies osimertinib, also known by the brand name Tagrisso, as the drug associated with the FDA action. It does not provide details about the drug’s class, mechanism, approved uses before this action, or the condition addressed by the supplement. It also does not include prevalence figures or clinical evidence supporting the application. Those details therefore cannot be established from this record alone.
The event is described as FDA approval of a supplemental application, rather than as an initial approval. The record’s “Efficacy” classification identifies the general category of the supplement, but does not explain what efficacy question was considered, what population was involved, or how the drug performed. No specific change to the product’s indication or labeling is provided in the supplied data.
What this means
The record documents an FDA action on a supplemental application for osimertinib on March 30, 2017. It does not provide enough information to characterize the clinical basis or practical scope of that action. In particular, the supplied data contain no trial design, patient population, comparator, endpoint, numerical outcome, safety finding, or p-value. They also do not identify whether the supplement added or changed an indication. Readers seeking those details should consult the FDA application record and associated documents rather than infer them from the efficacy classification alone.
Source
Source: FDA, drug application record for Tagrisso (osimertinib), NDA 208065, supplemental application 6, classified as “Efficacy”; event date March 30, 2017. The supplied source URL is hosted at accessdata.fda.gov.