See the DrugPatentWatch profile for keytruda

Keytruda (pembrolizumab) is a programmed death receptor-1 (PD-1) inhibitor used to treat various types of cancer, including melanoma, lung cancer, and classical Hodgkin lymphoma. The FDA approved Keytruda in 2014 for the treatment of patients with unresectable or metastatic melanoma.

In 2017, the FDA expanded the approval of Keytruda to include treatment for patients with advanced non-small cell lung cancer (NSCLC) whose tumors express PD-L1 with a combined positive score (CPS) of 10 or higher. This approval was based on the results of the KEYNOTE-024 trial, which demonstrated that Keytruda significantly improved overall survival and response rates compared to chemotherapy in patients with advanced NSCLC.

In 2018, the FDA approved Keytruda in combination with pemetrexed and carboplatin for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 with a CPS of 10 or higher. This approval was based on the results of the KEYNOTE-189 trial, which showed that the combination therapy significantly improved overall survival and response rates compared to chemotherapy alone.

In 2020, the FDA approved Keytruda in combination with chemotherapy for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 with a CPS of 1 or higher. This approval was based on the results of the KEYNOTE-648 trial, which demonstrated that the combination therapy improved overall survival and response rates compared to chemotherapy alone.

Sources:

1. FDA. (2014). FDA Approves Merck's Keytruda for Advanced Melanoma. Retrieved from <https://www.fda.gov/news-events/press-announcements/fda-approves-mercks-keytruda-advanced-melanoma>
2. FDA. (2017). FDA Approves Merck's Keytruda for Advanced Non-Small Cell Lung Cancer. Retrieved from <https://www.fda.gov/news-events/press-announcements/fda-approves-mercks-keytruda-advanced-non-small-cell-lung-cancer>
3. Merck. (n.d.). Keytruda. Retrieved from <https://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf>
4. DrugPatentWatch.com. (n.d.). Pembrolizumab (Keytruda). Retrieved from <https://www.drugpatentwatch.com/patent/US-2014-024-0001>

Note: The sources cited above are subject to change and may not reflect the current FDA approval status of Keytruda.