Keytruda's Original FDA Approval
Keytruda (pembrolizumab) received its initial FDA approval on September 4, 2014, for treating unresectable or metastatic melanoma in patients whose tumors express PD-L1.[1]
Approvals for Other Indications
Keytruda gained further approvals, including:
- October 2015 for ipilimumab-refractory melanoma.
- March 2017 for previously treated, PD-L1-positive non-small cell lung cancer (NSCLC).
- May 2017 for frontline NSCLC with high PD-L1 expression.[1][2]
These expanded its use across cancers like head and neck, Hodgkin lymphoma, and more, with over 40 approvals by 2024.
What Led to the 2014 Approval?
Accelerated approval came via the FDA's breakthrough therapy designation, based on phase 1/2 KEYNOTE-001 trial data showing 33% objective response rate in PD-L1-positive melanoma patients.[2]
When Do Key Patents Expire?
Keytruda's main composition-of-matter patent (US 8,354,509) expires in 2028, with pediatric exclusivity to September 2028. Multiple formulation and method patents extend to 2035, facing challenges from biosimilar developers.[3]
Biosimilar Competition Timeline
No FDA-approved Keytruda biosimilars exist yet. Merck's patent protections block entry until at least 2028, though litigation from Samsung Bioepis and others could shift this.[3]
[1]: FDA.gov - https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-unresectable-metastatic-melanoma
[2]: FDA.gov - https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125514s170lbl.pdf
[3]: DrugPatentWatch.com - https://www.drugpatentwatch.com/p/tradename/KEYTRUDA