Keytruda's Initial FDA Approval
Keytruda (pembrolizumab) received its first FDA approval on September 4, 2014, for treating unresectable or metastatic melanoma in patients whose tumors express PD-L1.[1]
Approvals for Other Cancers
The FDA granted subsequent approvals starting in 2015:
- May 2015: Ipilimumab-refractory melanoma.
- October 2015: Non-small cell lung cancer (NSCLC) expressing PD-L1.
- March 2017: Head and neck squamous cell carcinoma.[1][2]
By 2024, Keytruda has over 40 approvals across cancers like breast, bladder, and gastric.[2]
Why Multiple Approvals Matter
These build on the initial nod through supplemental applications, expanding use based on clinical trials showing efficacy in PD-1 inhibition.[1]
When Do Keytruda Patents Expire?
Core composition-of-matter patents expire around 2028 in the US, with others extending to 2036; challenges from generics could shorten exclusivity.[3]
[1]: FDA Approval History for Keytruda
[2]: Keytruda Prescribing Information
[3]: DrugPatentWatch.com - Keytruda Patents