Keytruda's Initial FDA Approval
Keytruda (pembrolizumab), Merck's PD-1 inhibitor, received its first FDA approval on September 4, 2014, for treating unresectable or metastatic melanoma in adults who had received prior ipilimumab and a BRAF inhibitor if BRAF V600 mutation-positive.[1][2]
How Keytruda Got Approved So Fast
The FDA granted accelerated approval based on tumor response rates and duration from the KEYNOTE-001 trial, where 33% of patients responded, with 40% of responses lasting a year or more. Full approval followed in 2015 after confirmatory data.[1]
First Expansions After 2014
- December 2014: Non-small cell lung cancer (NSCLC) with PD-L1 expression ≥50%, post-platinum chemo (KEYNOTE-001).[1]
- 2015-2016: Head and neck squamous cell carcinoma, classical Hodgkin lymphoma, urothelial carcinoma.[2]
Over 40 indications now, covering 20+ cancers.[3]
Why This Matters for Patients Today
Initial approval marked the start of checkpoint inhibitor era, shifting melanoma survival from months to years for responders. Median overall survival hit 38 months in later melanoma trials.[1]
Patent and Generic Timeline
Keytruda's key composition-of-matter patent (U.S. Patent No. 8,354,509) expires in 2028, but method-of-use patents extend to 2036. Challenges from Amgen, Samsung Bioepis, and others are ongoing; no generics until at least 2028.[4]
[1]: FDA Approval Letter, Keytruda (Sep 4, 2014). https://www.accessdata.fda.gov/drugsatfdadocs/label/2014/125514lbl.pdf
[2]: FDA Oncology Approvals Timeline. https://www.fda.gov/drugs/resources-information-approved-drugs/hematologyoncology-cancer-approvals-safety-notifications
[3]: Merck Keytruda Label (current). https://www.accessdata.fda.gov/drugsatfdadocs/label/2023/125514s173lbl.pdf
[4]: DrugPatentWatch.com - Keytruda Patents. https://www.drugpatentwatch.com/p/tradename/KEYTRUDA