Osimertinib fda approval date 2015?

See the DrugPatentWatch profile for Osimertinib

What was the FDA approval date for osimertinib (Tagrisso) in 2015?

Osimertinib (brand name Tagrisso) received FDA approval in 2015, with the approval date of November 13, 2015. [1]

What was osimertinib approved for when it first came to the FDA in 2015?

At launch, osimertinib was approved for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors had an EGFR T790M mutation and had progressed on or after EGFR TKI therapy. [1]

Why do people sometimes see different dates for osimertinib?

Different dates can appear depending on whether a source is reporting:
- the original FDA approval date, or
- later FDA label expansions or supplementary approvals after 2015.

The original 2015 FDA approval date for osimertinib remains November 13, 2015. [1]

Sources

[1] https://www.drugs.com/approval_process/osimertinib.html