Keytruda's Initial FDA Approval
Keytruda (pembrolizumab) received its first FDA approval in 2014 for unresectable or metastatic melanoma.[1]
First Additional Approval for Other Cancers (2015)
In 2015, Keytruda gained its first additional approvals for cancers beyond melanoma:
- October 2015: Head and neck squamous cell carcinoma (HNSCC), as second-line treatment.[1]
- Also 2015: Non-small cell lung cancer (NSCLC), marking expansion into thoracic cancers.[1]
These built on the initial approval, with NSCLC specifically approved in October 2015 for patients with PD-L1-positive tumors.[2]
Subsequent Expansions (2016–2017)
Approvals accelerated:
- 2016: Classical Hodgkin lymphoma (May) and further NSCLC indications.[1]
- 2017: Urothelial carcinoma, gastric cancer, and cervical cancer, among others.[1][2]
By 2017, Keytruda had approvals across 7+ cancer types, driven by PD-1 inhibitor data.
Why Multiple Approvals in Quick Succession?
Merck's Keytruda leveraged accelerated and breakthrough designations, with trials like KEYNOTE-001/024 showing rapid efficacy in PD-L1+ tumors across histologies.[2] FDA prioritized based on unmet needs in immunotherapy.
Full Timeline of Cancer Indications
| Year | New Cancer Types Approved |
|------|---------------------------|
| 2014 | Melanoma |
| 2015 | NSCLC, HNSCC |
| 2016 | Hodgkin lymphoma, urothelial (expanded) |
| 2017 | MSI-H cancers, gastric, cervical |
| 2018+ | Breast, endometrial, more NSCLC combos [1][2] |
Over 30 indications by 2024.[1]
Patent and Exclusivity Status
Keytruda's composition-of-matter patent expires in 2028 (U.S. Patent 8,354,509), with formulation patents to 2030+. Challenges from biosimilar makers like Samsung Bioepis are ongoing.3
[1]: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-keytruda-combination-chemotherapy-msi-h-dmmr-advanced-or-metastatic-gastric
[2]: https://www.merck.com/news/merck-receives-7th-new-indication-for-keytruda-pembrolizumab-first-line-treatment-of-patients-with-nsclc-expressing-pd-l1/