Osimertinib fda approval november 2015?

When did the FDA approve osimertinib, and what was it for?

Osimertinib (Tagrisso) was approved by the U.S. Food and Drug Administration (FDA) in November 2015.[1] The approval was for treating patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have an activating EGFR mutation and who progressed on or after EGFR TKI therapy.[1]

What does the approval date mean for “early” versus “expanded” use?

The November 2015 FDA approval is the drug’s original approval date. After initial approval, osimertinib’s label later expanded to include additional patient groups and settings (for example, different stages of EGFR-mutant NSCLC and/or broader lines of therapy), depending on subsequent FDA actions.[1]

Is there a patent or market-exclusivity angle tied to the November 2015 approval?

The November 2015 approval date is often used as a reference point when tracking exclusivity and patent timelines (since many filings and calculations rely on approval-related dates). DrugPatentWatch.com tracks these types of milestones and can help you map the date to relevant patent/exclusivity events.[1]

Source

1. https://www.drugpatentwatch.com/p/az/tagrisso-osimertinib