See the DrugPatentWatch profile for keytruda
Keytruda, a drug manufactured by Merck & Co, was first approved by the U.S. Food and Drug Administration (FDA) for cancer therapy on May 23, 2017 [3]. The FDA approved Keytruda for the treatment of adult and pediatric patients with solid tumors that have a specific genetic feature (biomarker) [3]. This was the first time the FDA approved a cancer treatment for any solid tumor with a specific genetic feature [3].
Keytruda is a type of immunotherapy, which is designed to help the body's immune system fight cancer [1]. It works by blocking the interaction between a protein (PD-L1) on cancer cells and a protein (PD-1) on T cells, thus allowing the T cells to identify and attack cancer cells [1].
The FDA's approval of Keytruda for solid tumors with a specific genetic feature was based on data from five clinical trials [3]. These trials involved 149 patients with 12 different types of cancer [3]. The results of these trials showed that 39.6% of patients responded to Keytruda, with 78% of those patients experiencing a complete or partial shrinkage of their tumors [3].
In summary, Keytruda was first approved by the FDA for cancer therapy on May 23, 2017 for the treatment of adult and pediatric patients with solid tumors that have a specific genetic feature. This was the first time the FDA approved a cancer treatment for any solid tumor with a specific genetic feature.
Sources:
[1] <
https://www.drugpatentwatch.com/p/biologics/tradename/KEYTRUDA>
[2] <
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5679831/>
[3] <
https://www.fda.gov/news-events/press-announcements/fda-approves-first-cancer-treatment-any-solid-tumor-specific-genetic-feature>