Keytruda's Initial FDA Approval for Cancer Treatment
Keytruda (pembrolizumab), made by Merck, received its first U.S. FDA approval on September 4, 2014, for unresectable or metastatic melanoma in patients whose tumors express PD-L1.[1]
Approvals for Other Cancers
Keytruda has since gained approvals for over 30 cancer indications, often through accelerated pathways:
- Non-small cell lung cancer (first-line, PD-L1 positive): October 2, 2015.
- Classical Hodgkin lymphoma: March 14, 2017.
- Head and neck squamous cell carcinoma: May 10, 2017.
- Triple-negative breast cancer: July 26, 2021.
Full list available on FDA's site or Merck's labeling.[1][2]
How Approvals Expanded Over Time
Merck pursued rapid label expansions via breakthrough therapy designations, with key additions tied to clinical trials like KEYNOTE-001 (melanoma) and KEYNOTE-024 (lung cancer). By 2024, it holds approvals across solid tumors, blood cancers, and MSI-H/dMMR tumors regardless of location.[2]
When Do Key Patents Expire?
Keytruda's main composition of matter patent (US 8,354,509) expires in 2028, though pediatric exclusivity pushes it to 2029. Formulation patents extend to 2033-2035. Challenges from Amgen, Samsung Bioepis, and others target earlier invalidation.3
Biosimilars and Market Competition
No U.S. biosimilars approved yet; first interchangeable versions (e.g., from Viatris) target post-2028 launch. European biosimilars like Bioeq's debuted in 2024 after EMA nod.3
[1]: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-monotherapy-first-line-treatment-metastatic-non-squamous-nsclc-pd-l1
[2]: https://www.merck.com/product/usa/picirculars/k/keytruda/keytrudapi.pdf