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Europe approves Keytruda for first-line head and neck squamous cell carcinoma, as a monotherapy or combo

Published on 20/11/19 at 12:39pm

MSD’s top-selling immunotherapy Keytruda (pembrolizumab) has secured another approval from the European Commission, this time in the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in patients whose tumours express PD-L1.

Phase 3 data supporting the application demonstrated that Keytruda significantly improved overall survival compared with standard treatment (cetuximab with carboplatin or cisplatin plus 5-FU), either as a monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy.

“This disease is especially debilitating since it can be highly visible and affect a patient’s appearance and their daily functions, such as eating and speaking,” said Professor Kevin Harrington, Professor of Biological Cancer Therapies at The Institute of Cancer Research, Consultant Clinical Oncologist at The Royal Marsden NHS Foundation Trust and investigator for the Keytruda trial. “Considering the great need for new treatment options, we are encouraged by today’s Keytruda approval in Europe, which will allow certain patients to be treated with immunotherapy earlier in the course of their treatment.”

Dr Jonathan Cheng, Vice President, Clinical Research at MSD, also commented: “Keytruda 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. The European Commission approval underscores our commitment to transforming the way cancer is treated around the world.”

Matt Fellows

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