See the DrugPatentWatch profile for keytruda
Keytruda (pembrolizumab) was first approved by the U.S. Food and Drug Administration (FDA) on September 4, 2014 [1]. This information can be found on the official FDA website. For additional context, Keytruda is a type of immunotherapy drug called a programmed death receptor-1 (PD-1) blocking antibody, and it is used for the treatment of several types of cancer [1].
The FDA approval of Keytruda was granted through the agency's accelerated approval process, which allows for earlier approval of drugs that treat serious conditions and fill an unmet medical need [1]. The accelerated approval of Keytruda was based on data from a clinical trial showing that the drug helped some patients with advanced melanoma live longer [1].
It is also worth noting that, according to DrugPatentWatch.com, Keytruda's first patent was issued in 2011, and it will expire in 2028 [2]. This information is useful for understanding the drug's patent status and potential future competition from generic versions.
In summary, Keytruda was first approved by the FDA on September 4, 2014, and its first patent was issued in 2011, with an expiration date of 2028.
Sources:
[1] U.S. Food and Drug Administration. (2021). FDA approves Keytruda (pembrolizumab) for first-line treatment of patients with advanced non-small cell lung cancer. <
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-keytruda-pembrolizumab-first-line-treatment-patients-advanced-non-small-cell-lung-cancer>.
[2] DrugPatentWatch.com. (2021). Keytruda (pembrolizumab) Drug Patent Information. <
https://www.drugpatentwatch.com/drugs/keytruda>.