Keytruda's Initial FDA Approval
Keytruda (pembrolizumab), made by Merck, received its first FDA approval on September 4, 2014, for unresectable or metastatic melanoma—a specific cancer type, not general therapy.[1]
Approvals for Other Cancers
The FDA has since expanded approvals to over 30 indications across various cancers, starting with:
- Non-small cell lung cancer (NSCLC) in October 2015.
- Head and neck squamous cell carcinoma in 2016.
- Classical Hodgkin lymphoma in 2017.[1][2]
No single "general cancer therapy" approval exists; approvals target specific indications based on clinical trials.
How Expansions Work
Keytruda's label grew through supplemental approvals, often via accelerated pathways for high unmet needs. By 2024, it covers MSI-H/dMMR solid tumors (first tissue/site-agnostic approval in 2017) and tumor mutational burden-high cancers (2020).[2]
Current Status and Timeline
As of 2024, Keytruda holds approvals for melanoma, NSCLC, renal cell carcinoma, endometrial carcinoma, and more. Full list and dates are on the FDA label.[1]
[1]: FDA Keytruda Label
[2]: FDA Approval History