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China’s NMPA Approves Astellas’ Zolbetuximab for Advanced Gastric and GEJ Cancer

NextEdge Admin

07 Jan 2025

2 min 28 sec

Astellas Pharma Inc. announced that China’s NMPA has approved VYLOY™ (zolbetuximab) in combination with fluoropyrimidine- and platinum-based chemotherapy for first-line treatment of locally advanced unresectable or metastatic HER2-negative gastric and gastroesophageal junction (GEJ) adenocarcinoma with CLDN18.2-positive tumors. Zolbetuximab is the first NMPA-approved monoclonal antibody targeting CLDN18.2, marking a significant advancement in precision oncology.

Gastric cancer is the third leading cause of cancer-related mortality in China, with over 260,000 deaths in 2022. Due to late-stage diagnosis in about 60% of cases, treatment options remain limited, with a five-year survival rate of only 9.1%.

The approval is based on global Phase 3 trials, GLOW and SPOTLIGHT, which included Chinese patients. The GLOW trial showed that zolbetuximab plus CAPOX improved median progression-free survival (PFS) to 8.21 months versus 6.80 months with placebo, and overall survival (OS) to 14.39 months versus 12.16 months. In SPOTLIGHT, zolbetuximab plus mFOLFOX6 resulted in a median PFS of 10.61 months versus 8.67 months and OS of 18.23 months versus 15.54 months. Safety profiles were consistent, with nausea, vomiting, and decreased appetite as common adverse events.

Experts from Sun Yat-sen University and the Chinese PLA General Hospital emphasized that zolbetuximab’s efficacy in Chinese patients aligns with global data, offering a valuable first-line treatment option.

With approximately 35% of Chinese patients having CLDN18.2-positive tumors, zolbetuximab provides a targeted therapy that selectively eliminates these cells. Astellas has incorporated the approval's impact into its financial forecast for FY 2025, reinforcing its commitment to advancing cancer care in China.