Keytruda's Initial 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 after ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.[1]
What Condition Was It First Approved For?
The approval targeted advanced melanoma, marking Keytruda as the first PD-1 inhibitor approved in the US. It was granted accelerated approval based on tumor response rates and duration from two clinical trials (KEYNOTE-001).[1]
How Has Its Label Expanded Since 2014?
Keytruda gained 11 more FDA approvals by 2017, covering non-small cell lung cancer, head and neck squamous cell carcinoma, classical Hodgkin lymphoma, urothelial carcinoma, and microsatellite instability-high cancers. By 2024, it has over 40 indications across 18 cancer types, including first-line treatments combined with chemotherapy.[1][2]
When Do Keytruda Patents Expire?
Core composition-of-matter patents for pembrolizumab expire between 2028 and 2035, with some pediatric exclusivity extending to 2037. Multiple challenges from biosimilar developers like Samsung Bioepis and Viatris are ongoing, potentially allowing earlier generic entry.[3]
Who Makes Keytruda and What's the Competition?
Merck & Co. (MSD outside the US) manufactures and markets Keytruda, which generated $25 billion in 2023 sales. Competitors include Bristol Myers Squibb's Opdivo (nivolumab), Roche's Tecentriq (atezolizumab), and emerging biosimilars.[2][3]
[1]: FDA Approval History - https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-unresectable-metastatic-melanoma
[2]: Merck Press Release (2014-2024 Approvals) - https://www.merck.com/news/fda-approves-keytruda-pembrolizumab/
[3]: DrugPatentWatch.com - https://www.drugpatentwatch.com/p/tradename/KEYTRUDA