When Was Keytruda First FDA Approved?
Keytruda (pembrolizumab) received its initial FDA accelerated approval on September 4, 2014, for treating unresectable or metastatic melanoma in patients whose tumors express PD-L1.[1]
Keytruda's Approval Timeline by Indication
The FDA has granted multiple approvals for Keytruda since 2014, expanding its use across cancers:
- 2015: Added for ipilimumab-refractory melanoma and first-line advanced melanoma (full approval).[1]
- 2016: Non-small cell lung cancer (NSCLC) with PD-L1 expression.[1]
- 2017: Head and neck squamous cell carcinoma and urothelial carcinoma.[1]
- Ongoing: Over 40 approvals by 2024, including MSI-H/dMMR tumors, gastric cancer, and triple-negative breast cancer.[1]
Full list available on FDA's site or Keytruda's prescribing information.
Why Accelerated Approval in 2014?
FDA used accelerated approval based on tumor response rates and duration from the KEYNOTE-001 trial (ORR 33% in PD-L1+ melanoma).[2] Conversion to full approval required confirmatory trials like KEYNOTE-006.
How Does This Compare to Competitors Like Opdivo?
Opdivo (nivolumab) got FDA approval earlier in December 2014 for melanoma, but Keytruda led in NSCLC uptake due to PD-L1 companion diagnostics.[3]
When Do Keytruda Patents Expire?
Core composition of matter patent (US 8,354,509) expires December 22, 2028, with extensions possible to 2036 via pediatric exclusivity. Challenges from generics like Viatris ongoing.[4][5]
[1]: FDA Approval History for Keytruda
[2]: NEJM KEYNOTE-001 Results (2015)
[3]: FDA Opdivo Approvals
[4]: DrugPatentWatch.com - Keytruda Patents
[5]: USPTO Patent Details