Keytruda's First FDA Approval
Keytruda (pembrolizumab) received its initial US FDA approval on September 4, 2014, for unresectable or metastatic melanoma in patients whose tumors express PD-L1.[1][2]
Why Melanoma Was First
The approval stemmed from phase 1b KEYNOTE-001 trial data showing 33% objective response rate and durable responses in advanced melanoma patients.[2] Melanoma's high unmet need and PD-1 pathway relevance made it the lead indication.
Timeline of Subsequent Approvals
- 2015: Added ipilimumab-refractory melanoma; first-line melanoma.
- 2016: NSCLC (PD-L1 positive).
- 2017: Head and neck squamous cell carcinoma; urothelial carcinoma.
Keytruda now has over 40 indications across 18 cancers.[1]
Comparison to Other PD-1 Inhibitors
Keytruda beat Opdivo (nivolumab) to market by months—Opdivo approved December 2014 for melanoma. Both targeted immunotherapy's breakthrough in checkpoint inhibition.[2]
Current Melanoma Role and Alternatives
Keytruda remains first-line for advanced melanoma, often combined with Yervoy (ipilimumab). Five-year survival exceeds 50% in trials vs. historical 20-30%.[1]
[1]: FDA Keytruda Label
[2]: Keytruda Approval History