Keytruda's Initial FDA Approval
Keytruda (pembrolizumab), Merck's PD-1 inhibitor for advanced melanoma, received its first FDA approval on September 4, 2014.[1]
Key Approvals and Label Expansions
The FDA granted accelerated approval for unresectable or metastatic melanoma based on tumor response rates from the KEYNOTE-001 trial.[1] Full approval followed in 2015 after confirmatory data.[2]
Subsequent expansions include:
- October 2015: First-line metastatic non-small cell lung cancer (NSCLC) with PD-L1 expression.[1]
- March 2017: Head and neck squamous cell carcinoma.[1]
- 2018-2023: Multiple additions for MSI-H/dMMR cancers, triple-negative breast cancer, renal cell carcinoma, endometrial carcinoma, and esophageal cancer, often with companion diagnostics.[2][3]
As of 2024, Keytruda holds approvals for over 30 indications across 18 tumor types.[3]
How Approvals Happened So Fast
Keytruda's rapid timeline stemmed from breakthrough therapy designation in 2013, prioritizing review for unmet needs in immunotherapy.[1] Pembrolizumab outperformed chemotherapy in melanoma trials (response rate 33% vs. 9%).[2]
Current Status and Patent Timeline
Keytruda generated $25 billion in 2023 sales, dominating immuno-oncology.[3] U.S. patents extend to 2028 (composition-of-matter), with method-of-use patents challenged in ongoing litigation potentially allowing generics by 2025.[4] Exclusivity for some pediatric indications runs to 2025.[4]
Common Patient Questions on Approvals
Patients often ask about off-label use—Keytruda is restricted to FDA-labeled indications for reimbursement. Accelerated approvals require post-market studies; two pediatric indications converted to full approval in 2023.[2]
[1]: FDA Approval History for Keytruda
[2]: FDA Label for Pembrolizumab
[3]: Merck Keytruda Overview
[4]: DrugPatentWatch.com - Keytruda Patents