Tagrisso fda approval history drugs com?

Tagrisso (osimertinib) has several FDA approvals since its initial approval. Here are the key milestones:

- 2015: First FDA approval for metastatic EGFR T790M-mutant NSCLC after progression on prior EGFR-TKI therapy (3rd-generation EGFR TKI).

- 2018: Expanded to first-line therapy for metastatic NSCLC with EGFR mutations (exon 19 deletion or L858R).

- 2020: Approved as adjuvant therapy after surgical resection for adults with stage IB–IIIA NSCLC with EGFR-sensitizing mutations.

- There have been additional label expansions since then (including CNS/metastatic settings and other specific indications) via supplemental approvals.

If you want the exact dates and all the listed indications, you can see a detailed FDA approval history on Drugs.com. Just search for “Tagrisso FDA approvals” on drugs.com or visit the Tagrisso page and view the FDA approvals section. If you’d like, I can pull out the full, date-stamped timeline from that page.