The FDA has granted a priority review designation for pembrolizumab injection, 100 mg (Keytruda, Merck) as monotherapy or in combination with chemotherapy for the first-line treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
KEYNOTE-048, a randomized, open-label phase 3 trial, evaluated pembrolizumab monotherapy or pembrolizumab combination as first-line treatment in 882 patients with recurrent or metastatic HSNCC. The dual primary endpoints were overall survival and progression-free survival.
Head and neck cancer includes various tumors that develop in or around the throat, larynx, nose, sinuses, and mouth. Major risk factors include tobacco and heavy alcohol use, as well as infection with certain types of human papillomaviruses. It is estimated that there will be more than 65,000 new cases of head and neck cancer diagnosed this year in the U.S.
Pembrolizumab is an anti-PD-1 therapy that increases the immune system’s ability to help detect and fight tumor cells. It 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.
The FDA has set a target action date of June 10, 2019 for pembrolizumab.
Source: Merck, February 11, 2019