Keytruda's Original FDA Approval
Keytruda (pembrolizumab) received its initial FDA approval on September 4, 2014, for treating unresectable or metastatic melanoma.[1]
Key Approvals by Indication and Year
- 2015: Expanded to ipilimumab-refractory melanoma and first-line advanced melanoma combination therapy.[1]
- 2016: Added for recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).[1]
- 2017: Approved for microsatellite instability-high (MSI-H) solid tumors, marking the first tissue/site-agnostic cancer approval.[1]
- 2020: First-line non-small cell lung cancer (NSCLC) with PD-L1 expression ≥1%.[1]
- 2023: Added for high-risk, localized or locally advanced muscle-invasive bladder cancer adjuvant therapy.[1]
Over 40 approvals total, mostly expansions for various cancers like NSCLC, melanoma, and MSI-H tumors.[1]
How FDA Approvals Work for Keytruda
Merck's Keytruda, a PD-1 inhibitor immunotherapy, gains approvals via accelerated (priority review) or full pathways based on pivotal trials like KEYNOTE series. Each targets specific biomarkers (e.g., PD-L1, MSI-H) or combinations.[1][2]
Current Status and Exclusivity
Keytruda remains under patent until around 2028 in the US, with pediatric exclusivity to 2029. No biosimilars approved yet.[3]
Common Patient Questions on Approvals
Patients often ask about off-label use (possible but not FDA-backed) or access via compassionate use programs pre-approval.[2]
[1]: FDA Approval History for Keytruda
[2]: Keytruda Prescribing Information
[3]: DrugPatentWatch.com - Keytruda Patents