When Was Keytruda First Approved?
Keytruda (pembrolizumab), Merck's PD-1 inhibitor for cancer treatment, received its initial FDA approval in 2014 for advanced melanoma.[1]
Keytruda's Approval Timeline by Indication
- 2014: Unresectable or metastatic melanoma.
- 2015: Expanded to non-small cell lung cancer (NSCLC) and head/neck squamous cell carcinoma.
- 2017: First-line NSCLC and Hodgkin lymphoma.
- 2019+: Dozens more, including breast, bladder, and gastric cancers; over 40 indications by 2024.[1][2]
Full list at FDA's site tracks expansions through supplemental approvals.
Why the Fast Expansions?
Keytruda's broad efficacy in immunotherapy trials led to accelerated approvals via FDA's breakthrough therapy designation, shortening review times.[2]
How Does This Compare to Competitors Like Opdivo?
Opdivo (nivolumab, Bristol Myers Squibb) approved slightly earlier in 2014 for melanoma, but Keytruda overtook in sales ($25B in 2023 vs. Opdivo's $9B) due to more indications and better NSCLC data.[3]
Patent and Exclusivity Outlook
Keytruda's core composition-of-matter patent expires in 2028 in the US, with extensions to 2035 for methods-of-use; biosimilars unlikely before then amid ongoing litigation.[4]
[1]: FDA.gov - Drugs@FDA: Pembrolizumab approval history (hyperlink: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125514)
[2]: Merck.com - Keytruda prescribing information (hyperlink: https://www.merck.com/product/usa/picirculars/k/keytruda/keytrudapi.pdf)
[3]: Evaluate.com - 2023 oncology sales data
[4]: DrugPatentWatch.com - Keytruda patents (hyperlink: https://www.drugpatentwatch.com/p/tradename/KEYTRUDA)