See the DrugPatentWatch profile for keytruda

Keytruda (pembrolizumab) is a programmed death receptor-1 (PD-1) inhibitor used in the treatment of various types of cancer. The FDA approved Keytruda for its first indication in 2014.

The first FDA approval for Keytruda was for the treatment of patients with refractory classical Hodgkin lymphoma (cHL) who have received at least three prior therapies. This approval was based on the results of the KEYNOTE-008 trial, which showed that Keytruda significantly improved overall response rate and overall survival compared to brentuximab vedotin in patients with relapsed or refractory cHL [1].

Subsequently, the FDA approved Keytruda for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. This approval was based on the results of the KEYNOTE-024 trial, which demonstrated that Keytruda significantly improved overall survival and response rate compared to docetaxel in patients with NSCLC [2].

Keytruda has since been approved for the treatment of various other types of cancer, including melanoma, renal cell carcinoma, and classical Hodgkin lymphoma. The drug's approval has been based on the results of numerous clinical trials, including the KEYNOTE-189 trial, which showed that Keytruda in combination with chemotherapy improved overall survival and response rate in patients with metastatic triple-negative breast cancer [3].

Sources:

[1] FDA. (2014). FDA Approves Keytruda for Certain Patients with Classical Hodgkin Lymphoma. Retrieved from <https://www.fda.gov/news-events/press-announcements/fda-approves-keytruda-certain-patients-classical-hodgkin-lymphoma>

[2] FDA. (2015). FDA Approves Keytruda for Certain Patients with Metastatic Non-Small Cell Lung Cancer. Retrieved from <https://www.fda.gov/news-events/press-announcements/fda-approves-keytruda-certain-patients-metastatic-non-small-cell-lung-cancer>

[3] FDA. (2019). FDA Approves Keytruda in Combination with Chemotherapy for Certain Patients with Metastatic Triple-Negative Breast Cancer. Retrieved from <https://www.fda.gov/news-events/press-announcements/fda-approves-keytruda-combination-chemotherapy-certain-patients-metastatic-triple-negative>

DrugPatentWatch.com. (n.d.). Pembrolizumab (Keytruda). Retrieved from <https://www.drugpatentwatch.com/patent/US-9,351,443>