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.
ヨーロッパでは、PD-L1バイオマーカーPositiveな食道がん患者に対して、初回化学療法としてのケモ＋Pembroが承認されたとか。へえ。。
