Keytruda's First FDA Approval Year
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 Approved For Initially?
The initial approval targeted advanced melanoma, marking Keytruda as the first PD-1 inhibitor approved in the US. This accelerated approval was based on tumor response rates from KEYNOTE-001 trial data.[1][2]
How Has the Approval Timeline Expanded?
Keytruda now has over 40 FDA approvals across cancers like non-small cell lung cancer (2015), head and neck squamous cell carcinoma (2016), and many others. Major expansions include first-line NSCLC combo with pemetrexed and platinum in 2017, and MSI-H/dMMR solid tumors in 2017.[1][3]
When Do Key Patents Expire?
Core composition-of-matter patents for Keytruda expire in the early 2028-2030 range, with some method-of-use patents extending to 2035+. Challenges from biosimilar makers like Samsung Bioepis and Viatris are ongoing, potentially allowing earlier generic entry.[4]
Who Makes Keytruda and What's the Competition?
Merck & Co. (MSD outside US) markets Keytruda, the top-selling cancer drug with $25B+ in 2023 sales. Main rivals include Bristol Myers Squibb's Opdivo (nivolumab), Roche's Tecentriq (atezolizumab), and Regeneron's Libtayo (cemiplimab).[3][4]
[1]: FDA.gov - https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-unresectable-metastatic-melanoma
[2]: FDA Approval Letter (2014) - https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125514Orig1s000lbl.pdf
[3]: Merck.com - Keytruda Approvals Timeline
[4]: DrugPatentWatch.com - https://www.drugpatentwatch.com/p/tradename/KEYTRUDA