Core Insights - Zolbetuximab is the first and only therapy approved in the EU targeting claudin 18.2, a biomarker present in 38% of advanced gastric cancer patients [1][2] - The European Commission approved VYLOY™ (zolbetuximab) for first-line treatment in combination with chemotherapy for specific gastric cancer patients [1][2] - Clinical trials demonstrated significant improvements in progression-free survival (PFS) and overall survival (OS) with zolbetuximab compared to standard treatments [2][3] Company Developments - Astellas Pharma announced the approval of zolbetuximab in the EU, following earlier approvals in the UK and Japan [3] - The company has adjusted its financial forecast for the fiscal year ending March 31, 2025, to reflect the impact of this approval [4] - Astellas is collaborating with Roche on a companion diagnostic test to identify eligible patients for zolbetuximab treatment [5] Clinical Trial Results - The SPOTLIGHT trial showed a median PFS of 10.61 months for zolbetuximab plus mFOLFOX6 compared to 8.67 months for placebo [2][7] - The GLOW trial reported a median PFS of 8.21 months for zolbetuximab plus CAPOX versus 6.80 months for placebo [2][8] - Both trials indicated similar rates of serious treatment-emergent adverse events between zolbetuximab and control groups [2] Market Context - Gastric and gastroesophageal junction cancers are significant health concerns, with over 135,000 new cases diagnosed in Europe in 2022 [6] - These cancers are the sixth leading cause of cancer-related deaths in Europe, highlighting the need for effective treatment options [6] - The average five-year survival rate for patients with these cancers in Europe is only 26%, emphasizing the urgency for new therapies [6]
Astellas Receives Approval from the European Commission for VYLOY™ (zolbetuximab) in Combination with Chemotherapy for Advanced Gastric and Gastroesophageal Junction Cancer