Approvals

The European Commission (EC) has approved Astellas Pharma’s VYLOY (zolbetuximab) in combination with fluoropyrimidine and platinum-containing chemotherapy as a treatment for adult patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)negative gastric or gastro-oesophageal junction (GEJ) adenocarcinoma whose tumours are claudin (CLDN) 18.2 positive.

Zolbetuximab is a claudin 18.2-directed cytolytic antibody that has been tested in the SPOTLIGHT and GLOW phase 3 clinical trials. It targets and binds to CLDN18.2, a transmembrane protein expressed on cancer cells, reducing the number of CLDN18.2-positive cells via antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity, leading to tumour growth inhibition.

This regulatory approval follows an approval from Japan’s Ministry of Health, Labour and Welfare in March 2024, and the UK Medicines and Healthcare products Regulatory Agency in August 2024.

Moitreyee Chatterjee-Kishore PhD MBA, senior vice president and head of Immuno-Oncolog y Development at Astellas Pharma, commented: “We are delighted to bring zolbetuximab, a first-in-class targeted treatment option, to patients in Europe where gastric and gastro-oesophageal cancers are the sixth leading cause of cancer-related death. With zolbetuximab, we’re entering a new era in precision medicine for these advanced cancers, underpinning our ongoing commitment to pioneering scientific discovery that can advance patient outcomes.”

In 2005, Astellas Pharma Inc. was established through the merger of the former Yamanouchi Pharmaceutical Co., Ltd and former Fujisawa Pharmaceutical Co., Ltd. Astellas Pharma is a pharmaceutical company based in Japan.