EMA accepts Astellas’ MAA for Zolbetuximab

Betsy Goodfellow | July 14, 2023 | News story | Medical Communications |  Astellas, Cancer, EMA, Oncology, zolbetuximab 

Astellas Pharma has announced that the European Medicines Agency (EMA) has accepted the company’s marketing authorisation application (MAA) for regulatory review for its drug zolbetuximab, a treatment for patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumours are CLDN18.2 positive.

If the drug is approved, it would become the first CLDN18.2-targeted therapy available in Europe for this patient group.

The MAA is based on results from the company’s phase 3 SPOTLIGHT and GLOW clinical trials, which evaluated the drug in combination with mFOLFOX6 and CAPOX, compared to placebo groups. In both trials, approximately 38% of patients had tumours that were CLDN18.2-positive.

A decision from the EMA’s Committee for Medicinal Products for Human Use (CHMP) is expected in 2024.

Moitreyee Chatterjee-Kishore, PhD MBA, senior vice president and head of Immuno-Oncology Development at Astellas, commented: “Patients with gastric cancer in Europe face extremely low five-year survival rates regardless of their disease stage, and innovative therapies that extend survival are needed. The EMA’s acceptance of the zolbetuximab MAA continues a cascade of regulatory milestones for Astellas that are aimed at bringing a new option to patients with advanced gastric and GEJ cancer.”

Betsy Goodfellow