When Was Keytruda First Approved by the FDA?
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 Expanded Keytruda's Approvals Over Time?
The FDA granted accelerated approval based on tumor response rates from the KEYNOTE-001 trial. Full approval followed in 2015 for melanoma after confirmatory data. Subsequent approvals came rapidly: non-small cell lung cancer in 2015, head and neck squamous cell carcinoma in 2016, and classical Hodgkin lymphoma in 2017, often under accelerated pathways with post-approval studies.[1][2]
How Many Indications Does Keytruda Have Now?
As of 2024, Keytruda holds 40 FDA approvals across 20+ tumor types, including first-line treatments for NSCLC, melanoma, and triple-negative breast cancer. Recent additions include high-risk endometrial carcinoma (2023) and HER2-positive gastric cancer (2024).[1][3]
When Do Keytruda Patents Expire?
Keytruda's core composition-of-matter patent (US 8,008,449) expires in 2028, but pediatric exclusivity pushes it to January 2029. Multiple formulation and method-of-use patents extend protection into the 2030s, with ongoing litigation against biosimilar challengers like Samsung Bioepis and Viatris.[4]
[1]: FDA.gov - Novel Drug Approvals for 2014 (https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2014)
[2]: FDA.gov - Pembrolizumab Approval History (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125514)
[3]: Merck.com - Keytruda Prescribing Information (https://www.merck.com/product/usa/picirculars/k/keytruda/keytrudapi.pdf)
[4]: DrugPatentWatch.com - Keytruda Patents (https://www.drugpatentwatch.com/p/tradename/KEYTRUDA)