EC approves two new regimens of Keytruda for HNSCC

The European Commission has given its approval to Keytruda to treat head and neck squamous cell carcinoma as a monotherapy or in combination with a chemotherapy.

The European Commission (EC) has approved Keytruda (pembrolizumab), as a monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy, for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC).

The drug, produced by Merck, is an injected humanised monoclonal antibody (mAb) that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, activating T lymphocytes, which may affect both tumour and healthy cells.

David Peacock, Managing Director, MSD UK and Ireland, said: “Current treatment options for people with metastatic or unresectable recurrent HNSCC are limited. We are 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 the National Institute for Health and Care Excellence (NICE) and the National Health Service (NHS) so patients will soon be able to gain access. At MSD, innovation is at the forefront of everything we do and we continue to strive towards improvements in outcomes for cancer patients.”

The approval is based on findings from a multi-centre, randomised, open-label, active-controlled Phase III trial, where Keytruda was compared with standard treatment of cetuximab with carboplatin or cisplatin plus 5-FU. The medicine demonstrated a significant improvement in overall survival.

“Keytruda is now the first anti-PD-1 treatment option in the first-line setting for metastatic or unresectable recurrent HNSCC, 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, Merck Research Laboratories. “The EC approval underscores our commitment to transforming the way cancer is treated around the world.”

The approval allows the marketing of Keytruda in all 28 member states plus Iceland, Lichtenstein and Norway.