Do you recall the year keytruda gained fda approval?

When Did Keytruda First Get FDA Approval?

Keytruda (pembrolizumab), Merck's PD-1 inhibitor for cancer treatment, received its initial FDA accelerated approval on September 4, 2014, for unresectable or metastatic melanoma.[1]

What Was the Original Indication?

The 2014 approval targeted patients with melanoma unresponsive to other therapies, marking one of the first immunotherapy breakthroughs for advanced skin cancer.[1]

Key Subsequent Approvals and Label Expansions

- 2015: Full approval for melanoma; first approval for non-small cell lung cancer (NSCLC) with PD-L1 expression.[1]
- 2017: Expanded to head and neck squamous cell carcinoma and urothelial carcinoma.[1]
- Ongoing: Now approved for over 30 indications, including MSI-H cancers regardless of tumor site.[1]

How Has Approval Timeline Affected Market Dominance?

Keytruda hit $25 billion in 2023 sales, driven by broad labels, but faces biosimilar challenges post-2028 patent cliffs.[2]

When Do Key Patents Expire?

Core composition-of-matter patents expire around 2028 in the US, with others extending to 2036; ongoing litigation from Amgen and others seeks earlier invalidation.[2]

[1]: FDA Approval History for Keytruda
[2]: DrugPatentWatch.com - Keytruda Patents