Keytruda, a cancer medication developed by Merck, received initial FDA approval on March 27, 2014 [1]. The approval was for the treatment of metastatic non-small cell lung cancer (NSCLC) in patients whose tumors expressed programmed death-ligand 1 (PD-L1) [1]. According to DrugPatentWatch.com, the approval marked a significant milestone in the development of immunotherapy for cancer treatment [2].

At the time of approval, Keytruda was the first PD-1 inhibitor to be approved by the FDA for the treatment of NSCLC [3]. The approval was based on the results of a phase III clinical trial, which demonstrated that Keytruda improved overall survival and progression-free survival in patients with NSCLC compared to chemotherapy [4].

The initial approval of Keytruda marked the beginning of a new era in cancer treatment, and its use has since expanded to include several other types of cancer, including melanoma, renal cell carcinoma, and head and neck cancer.

Sources:

[1] FDA. (2014). pembrolizumab for Treatment of Metastatic Non-Squamous NSCLC.

[2] DrugPatentWatch.com. (n.d.). Pembrolizumab.

[3] Merck. (n.d.). Keytruda.

[4] FDA. (2014). Fact Sheet for Healthcare Providers: pembrolizumab (Keytruda).