FX.co ★ Astellas: Zolbetuximab Combo Gets Positive CHMP Opinion In Advanced Gastric &Gastroesophageal Cancer

Astellas Pharma Inc. (ALPMY, ALPMY) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of zolbetuximab within the European Union. Zolbetuximab, a pioneering monoclonal antibody aimed at the claudin 18.2 (CLDN18.2) target, is advised for use in combination with fluoropyrimidine- and platinum-based chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma with CLDN18.2 positive tumors.

The European Commission will now review this positive opinion. If approved, zolbetuximab would be authorized for use across all 27 EU member states, as well as Iceland, Liechtenstein, and Norway.

Astellas has incorporated this development into its financial projections for the fiscal year ending March 31, 2025.

Beyond the EMA, Astellas has submitted zolbetuximab for approval to other regulatory bodies worldwide, all of which are currently reviewing the drug. Notably, zolbetuximab was approved in Japan by the Ministry of Health, Labour and Welfare (MHLW) in March 2024, making it the first and only CLDN18.2-targeted treatment approved by any regulatory agency globally.