Keytruda's First FDA Approval
Keytruda (pembrolizumab) received its initial FDA approval on September 4, 2014, for unresectable or metastatic melanoma in patients whose tumors express PD-L1.[1][2]
What the Approval Covered
The approval was based on data from the KEYNOTE-001 trial, showing a 33% objective response rate in PD-L1-positive melanoma patients.[1] It was granted under accelerated approval, requiring confirmatory trials.
How It Expanded from There
Subsequent approvals built on this:
- December 2014: Ipilimumab-refractory melanoma.
- October 2015: Full approval for advanced melanoma, dropping the PD-L1 requirement.[2]
By 2016, it reached first-line melanoma use.
Why Melanoma First
PD-1 inhibitors like Keytruda targeted melanoma early due to high unmet need and strong immunotherapy responses in trials—melanoma patients showed durable responses unlike many other cancers at the time.[1]
Current Approvals and Patent Status
Keytruda now has over 40 indications across cancers like lung, head/neck, and MSI-high tumors.[2] U.S. patents expire in 2028 (composition-of-matter), with exclusivity until 2025; challenges from biosimilar makers like Samsung Bioepis are ongoing.[3]
[1]: FDA Approval Letter, September 4, 2014. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125514lbl.pdf
[2]: FDA Oncology Approvals Timeline. https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications
[3]: DrugPatentWatch.com - Keytruda Patents. https://www.drugpatentwatch.com/p/tradename/KEYTRUDA