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][2]
What Was the Original Indication?
The approval covered advanced melanoma patients with specific PD-L1 expression or prior treatment failure. This accelerated approval was based on tumor response rates and duration from KEYNOTE-001 trial data.[1]
How Has Keytruda's Label Expanded Since 2014?
FDA granted additional approvals rapidly: non-small cell lung cancer (October 2015), head and neck squamous cell carcinoma (May 2016), and classical Hodgkin lymphoma (March 2017). By 2024, it has over 40 indications across 18 cancers, including first-line combinations.[2][3]
When Do Keytruda Patents Expire?
Core composition of matter patents expire between 2028 and 2035, with some pediatric exclusivity pushing to 2028-2036. Challenges from biosimilar makers like Samsung Bioepis target earlier entry.[4]
Who Makes Keytruda and What Drives Its Sales?
Merck & Co. markets Keytruda, the top-selling cancer drug with $25 billion in 2023 U.S. sales, fueled by broad immuno-oncology use.[2]
[1]: FDA.gov - Keytruda Approval History (https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-unresectable-metastatic-melanoma)
[2]: Merck.com - Keytruda Prescribing Information (https://www.merck.com/product/usa/picirculars/k/keytruda/keytrudapi.pdf)
[3]: FDA.gov - Novel Drug Approvals (https://www.fda.gov/drugs/novel-drug-approvals-fda)
[4]: DrugPatentWatch.com - Keytruda Patents (https://www.drugpatentwatch.com/p/tradename/KEYTRUDA)