Keytruda's First FDA Approval
Keytruda (pembrolizumab) received its initial FDA accelerated approval on September 4, 2014, for unresectable or metastatic melanoma in patients whose tumors express PD-L1 or who have progressed after ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.[1][2]
What specific melanoma patients qualified?
Approval targeted adults with inoperable or metastatic melanoma expressing PD-L1 in tumor cells, or those with disease progression following ipilimumab therapy and, for BRAF V600 mutation-positive cases, a BRAF inhibitor. This was based on interim results from the KEYNOTE-001 trial showing 33% objective response rate and durable responses.[1][3]
How did approval expand from melanoma?
Full approval for melanoma came in October 2015. Subsequent approvals followed rapidly: non-small cell lung cancer (October 2015, accelerated), head and neck squamous cell carcinoma (May 2016), and others, reaching over 40 indications by 2024.[2][4]
Why accelerated approval for melanoma first?
PD-1 inhibitors like Keytruda addressed unmet needs in immunotherapy-resistant melanoma, building on ipilimumab's success. Trial data showed tumor shrinkage in heavily pretreated patients, justifying priority review under FDA's accelerated pathway.[1][3]
When do Keytruda patents expire?
Core composition-of-matter patents for pembrolizumab expire in 2028 (U.S. Patent 8,354,509), with others extending to 2034+ via formulation and method claims. Challenges from biosimilar makers like Samsung Bioepis are ongoing.[5]
[1]: FDA Approval Letter, September 4, 2014. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125514s000lbl.pdf
[2]: FDA Oncology Approvals Timeline. https://www.fda.gov/drugs/resources-information-approved-drugs/hematologyoncology-cancer-approvals-safety-notifications
[3]: KEYNOTE-001 Trial (NEJM, 2015). https://www.nejm.org/doi/full/10.1056/NEJMoa1503098
[4]: Merck Keytruda Label History. https://www.keytruda.com/
[5]: DrugPatentWatch.com - Keytruda Patents. https://www.drugpatentwatch.com/p/tradename/KEYTRUDA