See the DrugPatentWatch profile for keytruda

Keytruda (pembrolizumab) received initial FDA clearance for the treatment of patients with unresectable or metastatic melanoma, specifically for patients with BRAF V600 wild-type or BRAF V600 mutation-positive melanoma. This clearance was granted on September 4, 2014, after the FDA reviewed data from a Phase I clinical trial, which demonstrated the drug's efficacy in treating this type of cancer.

According to the FDA's approval letter, Keytruda was shown to improve overall response rate, progression-free survival, and overall survival in patients with unresectable or metastatic melanoma compared to standard therapies. The FDA's approval was based on data from a Phase I trial, which included 135 patients with unresectable or metastatic melanoma who received Keytruda at a dose of 2 mg/kg every 3 weeks.

In addition to its initial FDA clearance for melanoma, Keytruda has since received approval for the treatment of various other cancers, including classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, and recurrent or metastatic cervical cancer with disease progression on or after platinum-based therapy.

Sources:

1. FDA. (2014, September 4). 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. Merck & Co., Inc. (n.d.). Keytruda (pembrolizumab) Prescribing Information. Retrieved from <https://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf>
3. DrugPatentWatch.com. (n.d.). Pembrolizumab (Keytruda) Patent Expiration. Retrieved from <https://www.drugpatentwatch.com/patent-expiration-dates/pembrolizumab-keytruda>

Note: The sources cited above are hyperlinked for easy access.