Keytruda's Initial FDA Approval for Cancer Treatment
Keytruda (pembrolizumab) received its first FDA approval on September 4, 2014, for unresectable or metastatic melanoma in adults and children.[1] This marked its entry for general cancer use, as the first PD-1 inhibitor approved in the US.
How Approval Expanded to Other Cancers
The FDA granted accelerated approval for melanoma based on tumor response rates from the KEYNOTE-001 trial. Full approval followed in 2015. Subsequent approvals broadened its use:
- October 2015: First-line treatment for metastatic nonsquamous non-small cell lung cancer (NSCLC), regardless of PD-L1 status.
- 2016-2017: Added for classical Hodgkin lymphoma, head and neck squamous cell carcinoma, and urothelial carcinoma.
By 2017, Keytruda had approvals across six cancer types, establishing it as a broad "general cancer" therapy.[1][2]
Key Milestones in Broad Cancer Approvals
| Year | Cancer Type | Notes |
|------|-------------|-------|
| 2014 | Melanoma | Initial approval; accelerated based on 33% response rate.[1] |
| 2015 | NSCLC | Expanded to ipilimumab-refractory cases; later first-line.[2] |
| 2016 | Hodgkin lymphoma | Pediatric approval included.[1] |
| 2017 | MSI-H/dMMR tumors | Tissue/site-agnostic approval for any solid tumor.[3] |
| 2020+ | Dozens more | Now approved for 30+ indications, including breast, endometrial, and MSI-high cancers.[1] |
Why 2014 Counts as 'General Cancer Use'
While targeted at melanoma initially, Keytruda's 2014 approval launched its role in immuno-oncology for multiple cancers. The FDA's tissue-agnostic approvals from 2017 onward (e.g., for MSI-H tumors) solidified broader use, but the 2014 nod was the starting point.[3]
[1]: FDA Approval History for Keytruda
[2]: Keytruda Label Updates
[3]: Tissue-Agnostic Approvals