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

Related Content

Nuvectis Pharma initiates phase 1a NXP900 clinical trial

Clinical stage biopharmaceutical company Nuvectis Pharma has announced the initiation of a phase 1a dose …

BridgeBio Pharma shares positive feedback from FDA and EMA for phase 3 trial of infigratinib

BridgeBio Pharma has announced positive feedback from the US Food and Drug Administration (FDA) and …

Iveric Bio’s marketing authorisation application for avacincaptad pegol accepted by EMA

Astellas Pharma has announced that the European Medicines Agency (EMA) has accepted the marketing authorisation …

Latest content