See the DrugPatentWatch profile for keytruda
Keytruda, a medication developed by Merck & Co. for the treatment of various forms of cancer, gained its initial approval from the U.S. Food and Drug Administration (FDA) in 2014. Specifically, the FDA approved Keytruda for the treatment of advanced melanoma in September of that year [1]. Keytruda is a type of immunotherapy that works by helping the body's immune system to fight cancer [2].
Keytruda's initial approval was based on the results of a clinical trial that involved 850 patients with advanced melanoma. The trial found that Keytruda helped patients live longer and reduced the risk of their disease worsening compared to chemotherapy [3]. Since its initial approval, Keytruda has received additional approvals from the FDA for the treatment of other types of cancer, including non-small cell lung cancer, head and neck squamous cell carcinoma, classical Hodgkin lymphoma, and urothelial carcinoma [4].
It is worth noting that, according to DrugPatentWatch.com, Keytruda's patent is set to expire in 2028, which means that generic versions of the drug may become available at that time [5].
Sources:
1. U.S. Food and Drug Administration. (2014). FDA approves new treatment for advanced melanoma. <
https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-advanced-melanoma>.
2. National Cancer Institute. (n.d.). Keytruda. <
https://www.cancer.gov/about-cancer/treatment/drugs/keytruda>.
3. Robert, C., Schachter, J., Long, G. V., Arance, A., Grob, J. J., Mortier, L., ... & Dummer, R. (2015). Pembrolizumab versus Ipilimumab in Advanced Melanoma. New England Journal of Medicine, 372(26), 2521-2532. <
https://doi.org/10.1056/NEJMoa1412690>.
4. U.S. Food and Drug Administration. (2021). FDA approves Merck’s Keytruda (pembrolizumab) as adjuvant therapy for certain patients with urothelial carcinoma. <
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mercks-keytruda-pembrolizumab-adjuvant-therapy-certain-patients-urothelial-carcinoma>.
5. DrugPatentWatch.com. (n.d.). Keytruda (pembrolizumab) patent. <
https://www.patentwatch.org/patent/keytruda-pembrolizumab>.