Keytruda's Original FDA Approval
Keytruda (pembrolizumab) received its first FDA approval in 2014 for treating unresectable or metastatic melanoma.[1]
Approvals for Other Cancers
The FDA has since expanded approvals:
- 2015: Ipilimumab-refractory melanoma and non-small cell lung cancer (NSCLC).
- 2017: Head and neck squamous cell carcinoma and urothelial carcinoma.
- Over 40 total indications by 2024, including breast, endometrial, and triple-negative breast cancers.[1][2]
Why Multiple Approvals Matter
These build on the initial 2014 nod, often via accelerated pathways based on clinical trials showing PD-1 inhibition benefits. Expansions reflect evolving data on tumor-agnostic use.[2]
Patent and Exclusivity Timeline
Keytruda's main composition-of-matter patent expires in 2028, with potential extensions to 2036 via pediatric exclusivity or litigation. Challenges from biosimilar makers like Samsung Bioepis are ongoing.[3]
[1]: FDA Approval History for Keytruda
[2]: Keytruda Label Updates
[3]: DrugPatentWatch: Keytruda Patents