See the DrugPatentWatch profile for keytruda

Pembrolizumab, marketed as Keytruda, is a cancer immunotherapy medication developed by Merck & Co. The exact date of its first FDA approval is September 4, 2014. [1]

On September 4, 2014, the FDA approved Pembrolizumab for the treatment of patients with unresectable or metastatic melanoma with disease progression following ipilimumab and, if BRAF V600 mutation-positive, a BRAF inhibitor. [2]

The FDA approval was based on the results of the KEYNOTE-001 trial, which demonstrated the efficacy and safety of Pembrolizumab in treating patients with advanced melanoma. [3]

According to DrugPatentWatch.com, Pembrolizumab's patent was filed on October 15, 2012, and was granted on October 15, 2013. [4]

The FDA approval of Pembrolizumab marked a significant milestone in the development of immunotherapy treatments for cancer, paving the way for its use in other indications and solidifying its position as a leading cancer treatment.

Sources:

[1] FDA. (2014). FDA Approves Pembrolizumab for Advanced Melanoma. Retrieved from <https://www.fda.gov/news-events/press-announcements/fda-approves-pembrolizumab-advanced-melanoma>

[2] FDA. (2014). Pembrolizumab (Keytruda) Approval Letter. Retrieved from <https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125514lbl.pdf>

[3] Hamid, O., et al. (2013). Safety and efficacy of pembrolizumab in patients with advanced melanoma: a phase 1b study. Journal of Clinical Oncology, 31(25), 3257-3264. doi: 10.1200/JCO.2012.47.0211

[4] DrugPatentWatch.com. (n.d.). Pembrolizumab (Keytruda) Patent. Retrieved from <https://www.drugpatentwatch.com/patent/US-8835551-B2>