Keytruda, a medication produced by Merck & Co., was initially approved by the U.S. Food and Drug Administration (FDA) in 2014. The FDA granted accelerated approval for Keytruda (pembrolizumab) to treat certain patients with advanced melanoma, based on the drug's tumor response rate and durability of response [3]. This information can be found in the FDA's announcement from September 2014 [3].
However, it is important to note that the FDA granted Keytruda a tissue site-agnostic indication in 2017, making it the first approved drug for this type of indication. This means that Keytruda can be used to treat adult and pediatric patients with solid tumors that have a specific genetic feature (biomarker) [1][2].
Sources:
1. DrugPatentWatch. Keytruda (pembrolizumab). <https://www.drugpatentwatch.com/p/biologics/tradename/KEYTRUDA>
2. National Center for Biotechnology Information. Pembrolizumab for the Treatment of Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Solid Tumors: Expanding the Indications for Immune Checkpoint Inhibitors. <https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5679831/>
3. U.S. Food and Drug Administration. FDA grants accelerated approval to pembrolizumab for advanced melanoma. <https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-pembrolizumab-first-tissuesite-agnostic-indication>