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Pembrolizumab, marketed as Keytruda, was first FDA-approved for cancer in 2014. It was initially approved for the treatment of patients with refractory classical Hodgkin lymphoma (cHL) who have received at least three prior therapies.

The FDA approval was based on the results of a clinical trial, which showed that Keytruda significantly improved overall response rate and overall survival compared to brentuximab vedotin, another treatment for cHL. [1]

In 2017, the FDA expanded the approval of Keytruda to include treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. [2]

Since then, Keytruda has been approved for the treatment of various types of cancer, including melanoma, non-small cell lung cancer, and head and neck squamous cell carcinoma, among others.

Sources:

[1] FDA. (2014, December 5). FDA Approves Pembrolizumab for Classical Hodgkin Lymphoma. Retrieved from <https://www.fda.gov/news-events/press-announcements/fda-approves-pembrolizumab-classical-hodgkin-lymphoma>

[2] FDA. (2017, March 24). FDA Approves Pembrolizumab for Cervical Cancer. Retrieved from <https://www.fda.gov/news-events/press-announcements/fda-approves-pembrolizumab-cervical-cancer>

[3] DrugPatentWatch.com. (n.d.). Pembrolizumab (Keytruda). Retrieved from <https://www.drugpatentwatch.com/patent/US-924-843-1>