¡Recent FDA approval for gastric and gastroesophageal junction cancer therapy!
New advances to combat a disease that is often diagnosed late
October 18 2024
In October 18 2024, FDA approved Vyloy™ (zolbetuximab-clzb), a treatment developed by Astellas Pharma, in combination with chemotherapy, for adult patients with gastric cancer or gastroesophageal junction (GEJ) in an advanced or metastatic state.
This treatment is specifically designed for patients whose tumors are HER2-negativ and present a high presence of the claudin 18.2 protein (CLDN18.2), which is determined by an immunohistochemical test approved by the FDA. In clinical trials conducted by Astellas, approximately 38% of patients had CLDN18.2-positive tumors.
These trials, called SPOTLIGHT and GLOW, showed that Vyloy, combined with chemotherapy, improved both progression-free survival and overall survival, compared with chemotherapy alone. The most common side effects observed in the studies included nausea, vomiting and decreased appetite.
Vyloy is the first and only approved treatment in the United States that specifically targets the CLDN18.2 protein.
In addition to its recent approval in the US., Astellas has also secured approval for Vyloy in other key countries, including Japan, the United Kingdom, the European Union and South Korea, reflecting its global impact in the treatment of advanced gastric cancer. This innovative medicine acts by precisely targeting cancer cells that express the CLDN18.2 protein, and eliminates them through mechanisms that activate the body’s immune system, including antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). The approval of Vyloy offers new hope for patients with gastric cancer, a disease that is often diagnosed in advanced stages when treatment options are limited and outcomes are often disappointing.
