Astellas Gains EU Approval for VYLOYTM with Chemotherapy in Advanced Gastric and Gastroesophageal Junction Cancer
Tuesday, September 24, 2024
Astellas Pharma has announced that the European Commission has approved VYLOYTM (zolbetuximab) in combination with chemotherapy for the first-line treatment of adults with locally advanced, unresectable, or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma, whose tumours are positive for claudin (CLDN) 18.2.
Zolbetuximab is the first monoclonal antibody specifically designed to target gastric tumour cells expressing the CLDN18.2 biomarker, marking a significant step forward in personalised cancer treatment.
Gastric and GEJ cancers are often diagnosed at an advanced stage, as early symptoms are similar to more common stomach conditions. Across Europe, over 135,000 new cases were diagnosed in 2022, with these cancers being the sixth leading cause of cancer-related deaths.
The approval follows recommendations from the European Medicines Agency to maintain zolbetuximab’s orphan medicinal product status due to the poor survival outcomes associated with these cancers.
In Phase 3 clinical trials, approximately 38% of patients with advanced gastric and GEJ cancers had CLDN18.2-positive tumours. By binding to CLDN18.2 on tumour cell membranes, zolbetuximab induces cytotoxicity and inhibits tumour growth.
Data from the SPOTLIGHT and GLOW clinical trials demonstrated statistically significant improvements in both progression-free survival (PFS) and overall survival (OS) in patients treated with zolbetuximab compared to standard chemotherapy.
In the SPOTLIGHT trial, patients treated with zolbetuximab plus mFOLFOX6 achieved a median PFS of 10.61 months and a median OS of 18.23 months. The GLOW trial reported similar efficacy, with a median PFS of 8.21 months and a median OS of 14.39 months for those treated with zolbetuximab plus CAPOX.
Common side effects included nausea, vomiting, and reduced appetite, with the incidence of serious adverse events being comparable to control groups.
The approval is valid across all 27 EU member states, as well as Iceland, Liechtenstein, and Norway. This aligns with updated European Society for Medical Oncology (ESMO) guidelines, which support the use of zolbetuximab in patients with CLDN18.2-positive, HER2-negative tumours.
Astellas is working to ensure patient access to the drug across Europe and has already secured regulatory approval in the UK and Japan.
Source: astellas.com
