The European Commission has approved MSD’s Keytruda (pembrolizumab) as monotherapy or as part of a combination, for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC).
The regulatory body says that the approval was based on data from the Phase III KEYNOTE-048 trial, in which the drug, compared with standard treatment (cetuximab with carboplatin or cisplatin plus 5-FU), demonstrated a significant improvement in overall survival (OS) as monotherapy and in combination with platinum and 5-fluorouracil (5-FU) chemotherapy.
Keytruda, MSD’s cancer blockbuster, works by increasing the ability of the body’s immune system to help detect and fight tumour cells. The approval now allows marketing of the drug monotherapy and combination regimen in all 28 EU member states plus Iceland, Lichtenstein and Norway.
As of the decision, it is “now the first anti-PD-1 treatment option in the first-line setting for metastatic or unresectable recurrent head and neck cancer, a disease that has been treated the same way in the EU for more than a decade,” said Dr Jonathan Cheng, vice president, clinical research, MSD Research Laboratories. “The European Commission approval underscores our commitment to transforming the way cancer is treated around the world.”
The news is important, as currently “treatment options for people with metastatic or unresectable recurrent head and neck squamous cell carcinoma are limited” explained David Peacock, managing director, MSD UK and Ireland.
He went on to say that the company is “very pleased to be able to offer two new treatment options which have the potential to address the unmet need in this devastating form of cancer. We are committed to working closely with NICE and the NHS so patients will soon be able to gain access.”
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. Two substances that greatly increase the risk of developing head and neck cancer are tobacco and alcohol, and it is estimated that there were more than 705,000 new cases of the cancer diagnosed and over 358,000 deaths from the disease worldwide in 2018.