Pembrolizumab fda approval date?

When was pembrolizumab first approved by the FDA?

Pembrolizumab (Keytruda) was first approved by the FDA on September 4, 2014.

What did the initial FDA approval cover?

That initial approval covered pembrolizumab for unresectable or metastatic melanoma that had progressed after treatment with ipilimumab and, if BRAF V600 mutation–positive, a BRAF inhibitor.

Has the FDA approval date changed with later indications?

The FDA approval date for the product itself remains the original 2014 approval date. What changes over time are FDA approval dates for new indications, which are added after the initial launch.

Want the approval history for specific cancers/indications?

If you tell me the cancer type (for example, NSCLC, renal cell carcinoma, head and neck cancer), I can narrow down the specific FDA label approval timing for that indication.