Who is the manufacturer of Vyloy (zolbetuximab-clzb)?

Vyloy (zolbetuximab-clzb) is a recombinant, chimeric, anti-claudin 18.2 (CLDN18.2) monoclonal antibody (mab) developed by Ganymed Pharmaceuticals. [5] Astellas Pharma acquired the rights to zolbetuximab when it acquired Ganymed Pharmaceuticals in December 2016. Vyloy is indicated for the treatment of patients with HER2-negative (HER2-), CLDN18.2-positive (CLDN18.2+) advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma and CLDN18.2+ advanced pancreatic cancer.

The active ingredient in Vyloy, zolbetuximab, is a monoclonal antibody (a protein) designed to attach to a protein called CLDN18.2, which is involved in keeping the cells lining the stomach tightly attached to each other. When these cells become cancerous, the CLDN18.2 protein is exposed, allowing zobetuximab to attach to the cancer cells. The immune system (the body's natural defense system) attacks and kills cancer cells and slows the progression of the disease.

It is used in conjunction with chemotherapy when the cancer is locally advanced (has spread nearby) and cannot be removed with surgery, or when it is metastatic (has spread to other parts of the body). Vyloy can be used when the cancer cells are HER2 negative and Claudin (CLDN) 18.2 positive; this means they don’t have a lot of HER2 receptors (targets) on their surface, but they have a lot of CLDN18.2 protein.

Vyloy is available by prescription only, and treatment should be initiated and supervised by a doctor experienced in cancer treatment. This medication is given by an intravenous infusion (drip) over at least 2 hours, every 2 or 3 weeks. Before each infusion, patients will be given medications to prevent nausea (feeling sick) and vomiting. Treatment can be continued as long as the treatment is effective or the side effects become unacceptable.