What year did keytruda receive fda approval?

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