When Was Keytruda First Approved?
Keytruda (pembrolizumab), Merck's PD-1 inhibitor for cancer treatment, received its initial FDA 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 solid tumors.[1]
How Has Keytruda's Label Expanded Since Then?
FDA granted additional approvals in 2015 for melanoma combination therapy, 2016 for NSCLC, and subsequent years for over 30 indications including head/neck cancers, Hodgkin lymphoma, and MSI-high tumors. By 2024, it holds approvals across 20+ cancer types.[1][2]
When Do Keytruda Patents Expire?
Core U.S. composition-of-matter patents for pembrolizumab expire in 2028, with formulation and method-of-use patents extending to 2030-2036. Challenges from Amgen, Samsung Bioepis, and others target earlier invalidation.[3]
Are Biosimilars on the Horizon?
No U.S. biosimilars are approved yet due to patent thickets and pediatric exclusivity pushing market entry to at least 2028. Europe saw first biosimilar approval in 2024 (Bioeq/MSD), but U.S. launch awaits litigation outcomes.[3]
[1]: FDA.gov - Novel Drug Approvals for 2014 (https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2014)
[2]: Merck.com - Keytruda Prescribing Information (https://www.merck.com/product/usa/picirculars/k/keytruda/keytrudapi.pdf)
[3]: DrugPatentWatch.com - Keytruda Patents (https://www.drugpatentwatch.com/p/tradename/KEYTRUDA)