Keytruda's Initial FDA Approval for Cancer
Keytruda (pembrolizumab) received its first FDA approval on September 4, 2014, for unresectable or metastatic melanoma in patients with BRAF V600 mutation-negative disease.[1]
Approvals for Other Cancer Types
The FDA has granted numerous subsequent approvals for Keytruda across cancer indications, often via accelerated pathways:
- October 2, 2015: Non-small cell lung cancer (NSCLC) as second-line therapy.[1]
- May 10, 2017: Head and neck squamous cell carcinoma.[1]
- June 2018: Classical Hodgkin lymphoma.[1]
- Expansions continue, with over 40 indications by 2024, including combinations with chemotherapy for triple-negative breast cancer (July 2021) and endometrial carcinoma (June 2024).[2]
Full list of approvals available on FDA's site or Keytruda's prescribing information.
Why Multiple Approvals Matter
Keytruda's approvals reflect its PD-1 inhibitor mechanism, which boosts immune response against tumors. Each requires separate clinical data, often from phase 3 trials like KEYNOTE studies, leading to label expansions every few months.
Current Status and Exclusivity
Keytruda remains under patent protection until around 2028 in the US, with pediatric exclusivity to 2029. No biosimilars approved yet; Merck holds market exclusivity.3
[1]: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-keytruda-nsclc
[2]: https://www.keytruda.com/