CHMP recommends approval of Keytruda in head and neck squamous cell carcinoma.- Merck Inc.

Merck announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending approval of two regimens of Keytruda (pembrolizumab) for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC). Keytruda as monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy, is recommended in patients whose tumors express PD-L1 (combined positive score [CPS] at least 1). This recommendation is based on data from the pivotal Phase III KEYNOTE-048 trial, in which Keytruda, as monotherapy and in combination with chemotherapy, demonstrated a significant improvement in overall survival, compared with standard treatment (cetuximab with carboplatin or cisplatin plus 5-FU), in these patient populations. The CHMP�s recommendation will now be reviewed by the European Commission for marketing authorization in the EU, and a final decision is expected in the fourth quarter of 2019.

Comment: Keytruda is an anti-PD-1 therapy that works by increasing the ability of the body�s immune system to help detect and fight tumor cells. 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.