Astellas Receives Positive CHMP Opinion for Zolbetuximab
EU Regulatory Committee Recommends Approval for First-in-Class Gastric Cancer Treatment
Tokyo, Japan - March 22, 2023 -
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D.) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the approval of zolbetuximab (brand name: VYLOY) in combination with chemotherapy for the treatment of adult patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) cancer.
Zolbetuximab is an investigational first-in-class chimeric IgG1 monoclonal antibody that targets and binds to Claudin 18.2 (CLDN18.2), a protein highly expressed on gastric and GEJ cancer cells. By binding to CLDN18.2, zolbetuximab is designed to block tumor cell proliferation, survival, and invasion, and to enhance the immune system's ability to recognize and attack cancer cells.
The CHMP's positive opinion is based on data from the Phase 3 DESTINY-Gastric01 trial, which evaluated the efficacy and safety of zolbetuximab in combination with chemotherapy in patients with locally advanced unresectable or metastatic gastric or GEJ cancer. The trial met its primary endpoint, demonstrating a statistically significant improvement in overall survival (OS) in patients treated with zolbetuximab plus chemotherapy compared to placebo plus chemotherapy.
The CHMP's recommendation will now be reviewed by the European Commission, which has the authority to grant marketing authorization for medicines in the European Union. A decision from the European Commission is expected in the coming months.
About Astellas
Astellas Pharma Inc., based in Tokyo, Japan, is a global pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. We focus on therapeutic areas with high unmet medical needs, including oncology, nephrology and immunology.
About Zolbetuximab
Zolbetuximab is a first-in-class chimeric IgG1 monoclonal antibody that targets and binds to CLDN18.2, a protein highly expressed on gastric and GEJ cancer cells. By binding to CLDN18.2, zolbetuximab is designed to block tumor cell proliferation, survival, and invasion, and to enhance the immune system's ability to recognize and attack cancer cells.
Zolbetuximab is currently under regulatory review in the European Union, the United States, and Japan for the treatment of gastric and GEJ cancer.
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