Merck’s Keytruda gets FDA approval

The FDA has approved Merck & Co’s market-leading PD-1 inhibitor Keytruda (pembrolizumab) as a monotherapy in metastatic small cell lung cancer untreatable with surgery or radiation therapy. Keytruda can enhance the body’s immune system and help detect and fight tumour cells by blocking the interaction between PD-1 and its ligands, PD-L1 and PD-L2. It then activates T lymphocytes, which may affect both cancerous and healthy cells.

Approval came on the back of results from the Keynote-158 (cohort G) and Keynote-028 (cohort C1) trials evaluating for efficacy through tumour response rate and durability of response. Of the 83 patients who took part, 64% received two prior lines of therapy and 36% received three or more lines. Additionally, 60% of patients received prior thoracic radiation therapy and 51% received prior radiation therapy.

Dr Jonathan Cheng, Merck Research Laboratories oncology clinical research vice-president, said: “Keytruda is already an established treatment option for non-small cell lung cancer, and today’s approval in small cell lung cancer demonstrates our commitment to bringing forward new treatment options for patients with advanced, difficult-to-treat cancers. We look forward to continuing to advance important clinical research in small cell lung cancer.”