Merck’s Keytruda Gains Esophageal Cancer Approval in Europe

The European Commission has approved Merck’s Keytruda (pembrolizumab) plus chemotherapy for treating certain patients with esophageal or gastroesophageal cancer.

The blockbuster immunotherapy is now approved in the EU as a first-line treatment for locally advanced unresectable or metastatic esophageal cancer or human growth factor receptor 2 (HER2)-negative gastroesophageal junction adenocarcinoma whose tumors express the PD-L1 biomarker.

The approval was supported by phase 3 data, which showed the antibody combined with platinum- and fluoropyrimidine-based chemotherapy significantly reduced the risk of death and disease progression vs. chemotherapy alone.

Keytruda with chemotherapy is the first anti-PD1 therapy approved in Europe for this first-line setting, said Scot Ebbinghaus, Merck’s vice president of clinical research.

Global Keytruda sales reached $14.4 billion in 2020.