Initial FDA Approval for Keytruda
Keytruda (pembrolizumab), developed 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
The FDA granted subsequent approvals for additional cancer indications:
- Non-small cell lung cancer (NSCLC): October 2, 2015, as first-line monotherapy for PD-L1-positive metastatic NSCLC.[1]
- Head and neck squamous cell carcinoma: Expanded approvals starting August 2016 for recurrent or metastatic cases.[1]
- Classical Hodgkin lymphoma: May 2017 for relapsed or refractory adult and pediatric patients.[1]
Keytruda now has over 40 indications across 19 cancers, with approvals continuing through accelerated and regular pathways.[2]
Approval Timeline Milestones
| Year | Key Cancer Approvals |
|------|----------------------|
| 2014 | Melanoma (first approval) |
| 2015 | NSCLC |
| 2016 | Head/neck cancer, bladder cancer |
| 2017 | Hodgkin lymphoma, urothelial carcinoma |
| 2018+ | Breast, gastric, MSI-H cancers, and combinations (e.g., with chemo for NSCLC) |
Approvals often started via accelerated pathways based on tumor response rates, later converted to full approval with survival data.[1][2]
How Keytruda's Approval Process Worked
Keytruda targets PD-1 to unleash immune response against tumors. Initial melanoma approval relied on KEYNOTE-001 trial data showing 33% objective response rate.[3] Expansions used basket trials for biomarkers like PD-L1 or MSI-H, speeding multi-cancer access.[2]
Global Approvals Outside U.S.
European Medicines Agency (EMA) approved Keytruda in July 2015 for advanced melanoma, followed by other regions like Japan (2016 for melanoma).[4]
Patent and Exclusivity Details
Merck holds patents on Keytruda until at least 2028 (U.S. Patent 8,354,509), with pediatric exclusivity to 2029. Challenges from biosimilar makers like Samsung Bioepis are ongoing.[5] Check DrugPatentWatch.com for latest expiry and litigation updates.[5]
[1]: FDA Approval History - https://www.fda.gov/drugs/resources-information-approved-drugs/keytruda-pembrolizumab
[2]: Merck Keytruda Label - https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125514s175lbl.pdf
[3]: KEYNOTE-001 Trial (NEJM, 2015) - https://www.nejm.org/doi/full/10.1056/NEJMoa1503098
[4]: EMA Keytruda Page - https://www.ema.europa.eu/en/medicines/human/EPAR/keytruda
[5]: DrugPatentWatch.com - https://www.drugpatentwatch.com/p/tradename/KEYTRUDA