Keytruda, a drug manufactured by Merck & Co., gained FDA approval for use in cancer therapy on September 4, 2014 [1]. Keytruda, also known as Pembrolizumab, is a type of immunotherapy that helps the body's immune system fight cancer cells [2]. The FDA approved Keytruda for the treatment of advanced melanoma in patients who have already been treated with other therapies and who cannot undergo surgery [1].

The FDA's accelerated approval of Keytruda was based on data from a clinical trial that showed Keytruda helped some patients with advanced melanoma live longer [1]. The trial included 173 patients who had already been treated with other therapies [1]. Of those patients, 34% experienced a partial shrinkage or complete disappearance of their tumors for an average of 2.1 months [1].

Keytruda works by blocking a protein called PD-1, which is produced by the body's immune system [2]. PD-1 helps keep the body's immune system from attacking cancer cells [2]. By blocking PD-1, Keytruda allows the body's immune system to recognize and attack cancer cells [2].

Since its initial approval, Keytruda has received additional FDA approvals for the treatment of other types of cancer [2]. As of 2021, Keytruda is approved for the treatment of 11 different types of cancer [2].

Sources:

[1] U.S. Food and Drug Administration. (2014, September 4). FDA approves new treatment for advanced skin cancer. <https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-advanced-skin-cancer>.

[2] DrugPatentWatch. (n.d.). Keytruda (pembrolizumab). <https://www.drugpatentwatch.com/drugs/keytruda>.