Merck, a global healthcare leader, announced that the US Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. The application is seeking approval for Keytruda as a single agent at a dose of 200 mg administered intravenously every three weeks. The FDA granted Priority Review with a PDUFA, or target action, date of August 9; the sBLA will be reviewed under the FDA’s Accelerated Approval programme.

“Starting in the early days of our development programme, we have explored the role of Keytruda for patients with head and neck cancer, a difficult-to-treat and debilitating disease with very few treatment options,” said Roger Dansey, M.D., senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories. “We are encouraged by the data emerging from our programme in this type of cancer, and welcome today’s news as this is an important step toward making Keytruda available to these patients.”

Merck currently has the largest immuno-oncology clinical development programme in head and neck cancer and is advancing multiple registration-enabling studies with Keytruda as a single agent and in combination with chemotherapy.

Keytruda is a humanized monoclonal antibody that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. Keytruda blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumour cells and healthy cells.

Keytruda is indicated in the United States for the treatment of patients with unresectable or metastatic melanoma.

Keytruda is also indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumours express PD-L1 as determined by an FDA-approved test with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumour aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Keytruda. The NSCLC indication is approved under accelerated approval based on tumour response rate and durability of response. An improvement in survival or disease-related symptoms has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Keytruda is administered at a dose of 2 mg/kg as an intravenous infusion over 30 minutes every three weeks for the approved indications.

Head and neck cancer describes a number of different tumours that develop in or around the throat, larynx, nose, sinuses and mouth. Most head and neck cancers are squamous cell carcinomas that begin in the flat, squamous cells that make up the thin surface layer of the structures in the head and neck. The leading modifiable risk factors for head and neck cancer include tobacco and heavy alcohol use. Other non-modifiable risk factors include infection with certain types of HPV, also called human papillomaviruses. Each year, worldwide, there are approximately 400,000 cases of cancer of the oral cavity and pharynx, in addition to approximately 160,000 cases of cancer of the larynx, resulting in approximately 300,000 deaths. In the US approximately 62,000 new cases of cancer of the oral cavity, pharynx and larynx are estimated to be diagnosed in 2016.