FDA approves two Tagrisso supplements for AstraZeneca

The FDA approved two supplemental applications for Tagrisso (osimertinib mesylate), AstraZeneca's oral tablet for non-small cell lung cancer, with a submission status date of 2026-09-14¹.

Supplement 35 was classified as an efficacy submission and received standard review priority before its approval. The associated approval letter and updated product label were dated 20260915 and 20260922, respectively¹.

Supplement 36 was a labeling submission, also under standard review priority, and was approved the same day. Its approval letter and label documents carried the same dates as the efficacy supplement, 20260915 and 20260922².

Both supplements apply to Tagrisso's two approved oral tablet strengths, containing osimertinib mesylate equivalent to 40MG base and 80MG base¹. The FDA's records list AstraZeneca as the sponsor¹ for both submissions under application number NDA208065¹.

The documents provided do not specify the clinical content of the efficacy supplement, such as new indications, trial data, or endpoint results supporting the labeling change. Further detail would require reviewing the linked approval letter and label documents directly.