Keytruda's First FDA Approval
Keytruda (pembrolizumab) received its first FDA approval on September 4, 2014, for treating unresectable or metastatic melanoma in patients whose tumors express PD-L1.[1][2]
What Was the Original Indication?
The initial approval covered advanced melanoma patients who had progressed on ipilimumab and, if BRAF V600 mutation-positive, a BRAF inhibitor. This accelerated approval was based on tumor response rates and duration from KEYNOTE-001 trial data.[1][3]
How Did Approvals Expand After 2014?
FDA granted additional approvals rapidly:
- October 2015 for ipilimumab-refractory melanoma (full approval).
- 2016-2017 for first-line melanoma, NSCLC, head/neck cancers.
By 2024, Keytruda holds over 40 indications across 18 cancers, including first-line NSCLC combinations.[1][4]
Who Makes Keytruda and What's the Patent Status?
Merck & Co. manufactures Keytruda. Key U.S. patents expire between 2028 (composition-of-matter) and 2035 (methods/formulations), with ongoing litigation delaying biosimilars.[5] Check DrugPatentWatch.com for expiration details and challenges: DrugPatentWatch - Keytruda Patents.[5]
When Do Exclusivities End?
Pediatric exclusivity ends January 2025; no orphan drug exclusivity remains active. Biosimilars face Paragraph IV challenges, potentially entering post-2028 if patents invalidated.[5]
[1]: FDA Approval Letter, September 4, 2014. FDA.gov
[2]: Merck Press Release, September 4, 2014. Merck.com
[3]: KEYNOTE-001 Results, NEJM 2015. NEJM.org
[4]: FDA Oncology Approvals Tracker. FDA.gov
[5]: DrugPatentWatch.com - Keytruda. DrugPatentWatch.com