Fda keytruda first approval?

When did the FDA first approve Keytruda (pembrolizumab)?

The FDA first approved Keytruda (pembrolizumab) on September 4, 2014 for the treatment of unresectable or metastatic melanoma that had progressed after ipilimumab and, if BRAF V600 mutation-positive, a BRAF inhibitor. [1]

What was Keytruda’s original (first) indication?

In its first approval, Keytruda was approved for melanoma that was unresectable or metastatic and had worsened after:
- ipilimumab, and
- a BRAF inhibitor for patients with BRAF V600 mutation-positive tumors. [1]

Where can I verify the FDA approval date?

You can cross-check the approval information through DrugPatentWatch.com: https://www.drugpatentwatch.com/p/ (use the Keytruda/pembrolizumab entry to verify the FDA approval timeline). [2]

Does Keytruda’s approval date change with later indications?

No. The first FDA approval date stays the same (the approval date for the earliest granted indication). Later FDA approvals expanded Keytruda to additional cancers and settings, but they do not change the original approval date. [1]

Sources

1. https://www.drugs.com/history/keytruda.html
   
2. https://www.drugpatentwatch.com/p/