Merck & Co. said Wednesday that the European Commission approved Keytruda (pembrolizumab), either as monotherapy or in combination with standard chemotherapy, for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in patients whose tumours express PD-L1 with a combined positive score (CPS) of at least 1.
"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," remarked Jonathan Cheng, vice president of clinical research at Merck Research Laboratories. The product gained FDA clearance in this indication in June.
Merck noted that the EU approval, which follows a positive opinion in October from the European Medicines Agency's Committee for Medicinal Products for Human Use, is based on findings from the Phase III KEYNOTE-048 trial. The company announced last year that the study had met its primary endpoint of overall survival, with later results indicating that Keytruda in combination with chemotherapy reduced the risk of death by 35% versus the EXTREME regimen, consisting of Merck KGaA's Erbitux (cetuximab) plus chemotherapy, in patients whose tumours expressed PD-L1 with a CPS of at least 1.
Last month, Merck reported that quarterly sales of Keytruda topped $3 billion for the first time, rising 62% from the year-ago period to $3.1 billion. For related analysis, see ViewPoints: Merck & Co. looks to lock out competitors with impressive Keytruda run rate.
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