Keytruda Approved for Cutaneous Squamous Cell Carcinoma

This approval comes days after Merck announced it would withdraw indication for third-line gastric cancer.

Merck has announced that it has received FDA approval for Keytruda (pembrolizumab) as monotherapy for the treatment of patients with locally advanced cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation. This approval is based on data from the second interim analysis of the phase 2 KEYNOTE-629 trial, which was a multicenter, multi-cohort, non-randomized, open-label trial.

Keytruda is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes, which may affect both tumor cells and healthy cells.

Merck recently announced it will voluntarily withdraw the U.S. indication for Keytruda for certain patients with gastric cancer or gastroesophageal junction adenocarcinoma whose tumors express PD-L1, who have seen their disease progress after at least two lines of therapy. The decision follows the April 29 hearing of the FDA Oncology Drugs Advisory Committee, where the panel recommended against continuing the indication. The decision does not affect other indications for Keytruda.

Keytruda is currently approved either as a single agent or in combination with other therapies to treat several cancers, including melanoma, non-small cell lung cancer, head and neck squamous cell cancer, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, urothelial carcinoma, microsatellite instability high colorectal cancer, esophageal cancer, cervical cancer, renal cell carcinoma, Merkel cell carcinoma, triple-negative breast cancer, and cutaneous squamous cell carcinoma.