Keytruda's Initial FDA Approval Year
Keytruda (pembrolizumab), developed by Merck, 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 on other therapies.[1][2]
Approvals for Other Cancers
Keytruda has gained approvals for multiple cancer types since 2014:
- Non-small cell lung cancer (NSCLC): First in October 2015 as second-line therapy.[2]
- Head and neck squamous cell carcinoma: May 2016.[2]
- Classical Hodgkin lymphoma: May 2017.[2]
- Urothelial carcinoma: May 2017.[2]
Over 40 indications by 2024, including MSI-H/dMMR tumors (2017) and HER2-positive gastric cancer (2021).[1][3]
Why Multiple Approvals Matter
These expand use from melanoma to first-line treatments across cancers, driving Keytruda's sales past $25 billion in 2023. Accelerated approvals often rely on tumor response rates, with full approvals following confirmatory trials.[2][3]
Patent and Exclusivity Timeline
Keytruda's main composition-of-matter patent expires in 2028, with pediatric exclusivity to 2029. Method-of-use patents extend protection into the 2030s, facing challenges from biosimilar developers like Samsung Bioepis.[4]
[1]: FDA Approval History
[2]: Keytruda Prescribing Information
[3]: Cancer.gov - Pembrolizumab
[4]: DrugPatentWatch.com - Keytruda Patents