Keytruda's First FDA Approval
Keytruda (pembrolizumab) received its initial FDA approval on September 4, 2014, for unresectable or metastatic melanoma in patients with BRAF V600 mutation-negative disease.[1][2]
Approvals for Other Cancer Types
The FDA granted accelerated approval for non-small cell lung cancer (NSCLC) on October 2, 2015.[1][3]
Subsequent approvals expanded to head and neck squamous cell carcinoma (2016), classical Hodgkin lymphoma (2017), urothelial carcinoma (2017), and more, reaching over 30 indications by 2024.[1][4]
Why the 2014 Approval Mattered
This breakthrough therapy designation sped up review based on phase 1/2 KEYNOTE-001 trial data showing 33% objective response rate and 9-month median duration in advanced melanoma.[2][5]
Timeline of Major Early Approvals
| Year | Cancer Type | Notes |
|------|-------------|-------|
| 2014 | Melanoma | First approval; ipilimumab competitor[1] |
| 2015 | NSCLC | PD-L1 positive; first immunotherapy in lung cancer[3] |
| 2016 | Head & neck | Recurrent/metastatic[1] |
| 2017 | Hodgkin lymphoma | Pediatric inclusion later[4] |
Current Status and Exclusivity
Keytruda holds blockbuster status with $25B+ annual sales. U.S. exclusivity runs through 2028, with patents extending to 2036 amid biosimilar challenges.[6][7]
[1]: FDA.gov - Novel Drug Approvals for 2014
[2]: FDA.gov - Keytruda Approval Letter (9/4/2014)
[3]: FDA.gov - Keytruda NSCLC Approval (10/2/2015)
[4]: FDA.gov - Keytruda Labels (updated 2024)
[5]: NEJM - KEYNOTE-001 Results (2015)
[6]: Drugs.com - Keytruda Timeline
[7]: DrugPatentWatch.com - Keytruda Patents