What year was keytruda approved for cancer treatment?

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.[1]

Approvals for Other Cancers

The FDA has since expanded approvals to over 30 indications across cancers like non-small cell lung cancer (2015), head and neck squamous cell carcinoma (2016), and many others through 2024, often via accelerated or full approvals based on clinical trials.[1][2]

How Approvals Evolved Over Time

• 2014: Melanoma (first approval).
  
• 2015: NSCLC and classical Hodgkin lymphoma.
  
• 2016-2018: Added urothelial carcinoma, MSI-H cancers, gastric cancer, and more.
  
• 2019-2021: Triple-negative breast cancer, endometrial cancer, renal cell carcinoma.
  
• 2022-2024: Esophageal cancer, HER2-positive gastric cancer, tumor agnostic uses.[1][2]
  
  Keytruda holds orphan drug exclusivity until 2025 for certain rare cancers and pediatric exclusivity until 2026.[3]
  
  

Patent Timeline and Biosimilar Outlook

Merck's key composition-of-matter patent for Keytruda expires in 2028 in the US, with potential extensions to 2030 via pediatric exclusivity. Challenges from competitors like Samsung Bioepis and Viatris are ongoing, but no biosimilars are approved yet.[3]

[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.fda.gov/drugs/resources-information-approved-drugs/pembrolizumab)
[3]: DrugPatentWatch.com - Keytruda Patents (https://www.drugpatentwatch.com/p/tradename/KEYTRUDA)