Keytruda's First FDA Approval
Keytruda (pembrolizumab) received its initial FDA accelerated approval on September 4, 2014, for unresectable or metastatic melanoma in patients with BRAF V600 mutation-negative tumors.[1]
Expansions to Broader ("Wide") Applications
The FDA has since approved Keytruda for over 40 indications across cancers like non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma, classical Hodgkin lymphoma, urothelial carcinoma, and microsatellite instability-high (MSI-H) cancers. Key expansion milestones include:
- October 2, 2015: First-line combination therapy with pemetrexed and carboplatin for metastatic nonsquamous NSCLC, marking its shift to frontline use in a high-prevalence cancer.[1][2]
- May 10, 2017: Approval for any MSI-H solid tumor regardless of cancer type, the first tissue/site-agnostic approval based on biomarker rather than histology.[1]
- June 2020 onward: Multiple adjuvant and neoadjuvant approvals, such as for resected high-risk melanoma (further expanded) and NSCLC perioperative use (October 2023).[1]
These built "wide application" through biomarker-driven (PD-L1, MSI-H, TMB-H) and combination regimens, now covering ~40% of U.S. cancer patients eligible.[2]
How Keytruda's Label Keeps Expanding
Merck submits supplemental Biologics License Applications (sBLAs) based on phase 3 trials like KEYNOTE-024 (NSCLC, 2016) and KEYNOTE-177 (MSI-H colorectal, 2020). Recent additions include triple-negative breast cancer (July 2021) and HER2-negative gastric cancer (2024).[1][3] Full list at FDA's site tracks ~100 approvals/revisions since 2014.
When Does Keytruda's Exclusivity End?
Primary U.S. patents expire in 2028, with pediatric exclusivity to 2028-2029; some method-of-use patents extend to 2036 amid ongoing litigation. Biosimilars unlikely before 2028, though challenges from Amgen and others target earlier entry.[4]
[1]: FDA Keytruda Approval History
[2]: FDA Labeling Updates
[3]: Merck Press Releases
[4]: DrugPatentWatch: Keytruda Patents