Singapore HSA has approved, Astellas Pharma Inc. VYLOY™ (zolbetuximab), an anti-claudin 18.2 (CLDN18.2) monoclonal antibody for patients with CLDN18.2 positive, unresectable or metastatic gastric or gastroesophageal cancer.
VYLOY™ is a CLDN18.2-targeted therapy approved in combination with chemotherapy for patients with human epidermal growth factor receptor 2 (HER2)-negative gastric, or gastroesophageal junction (GEJ) cancer, and is the first and only such therapy. Singapore is the first country in South-East Asia to receive approval.
“The approval of VYLOY™ in Singapore marks a new era in the targeted treatment of gastric and gastroesophageal cancer, offering a new treatment option to patients diagnosed with CLDN18.2 positive gastric or gastroesophageal cancer,” said Aycin Oguz, General Manager, Astellas Pharma Singapore and Malaysia.
“This approval introduces a critical therapy to eligible patients who face limited treatment options,” said Rebecca Chng, Head, Medical Affairs, Astellas Pharma Singapore and Malaysia. “In Singapore, gastric cancers are the 6th and 7th causes of cancer-related death in males and females respectively. VYLOY™’s approval is a positive step forward in treating this disease that is often diagnosed at an advanced stage. Zolbetuximab was first approved in Singapore on 6 March 2025.
