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 or who have progressed on ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.[1][2]
What Cancer Was It First Approved For?
The initial approval targeted advanced melanoma, marking the first PD-1 inhibitor approved for cancer treatment. This accelerated approval was based on tumor response rates from the KEYNOTE-001 trial.[1]
How Did Approvals Expand After 2014?
FDA granted additional approvals in 2015 for melanoma combination therapy and ipilimumab-refractory cases, then rapidly broadened to non-small cell lung cancer (2015), head and neck squamous cell carcinoma (2016), and others. By 2024, it has over 40 indications across 20+ cancer types.[2][3]
Who Makes Keytruda and When Do Patents Expire?
Merck & Co. manufactures Keytruda. Key U.S. composition-of-matter patents expire in 2028, with formulation patents extending to 2035 amid ongoing litigation. Exclusivity ends January 2028, opening doors for biosimilars.[4]
[1]: FDA.gov - https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-melanoma
[2]: Merck.com - Keytruda prescribing information
[3]: FDA approval history - https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125514
[4]: DrugPatentWatch.com - https://www.drugpatentwatch.com/p/tradename/KEYTRUDA