FDA Greenlights Astellas Gastric Cancer Therapy

The FDA has approved Astellas Pharma's zolbetuximab-clzb (Vyloy) in combination with chemotherapy for the initial treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma.

This approval is based on data from two pivotal clinical studies, SPOTLIGHT and GLOW, which demonstrated that patients receiving zolbetuximab-clzb in combination with chemotherapy had better progression-free and overall survival rates compared to those who were treated with chemotherapy alone. Alongside this approval, the FDA also sanctioned the use of the VENTANA CLDN18 RxDx Assay as an essential diagnostic tool to identify patients suitable for this treatment.

Zolbetuximab-clzb is administered through intravenous infusion, beginning with an initial dose of 800 mg/m2, followed by maintenance doses administered every two or three weeks, as necessary. The most frequently observed side effects associated with this medication include nausea, vomiting, and neutropenia.

The FDA's approval is specifically for patients whose tumors test positive for CLDN18.2, which is determined using an FDA-approved diagnostic test. This targeted approach ensures that the treatment is administered to individuals who are most likely to benefit from it.

Notably, zolbetuximab-clzb has received several special designations from the FDA, including priority review, fast track, and orphan drug designations. These designations are granted to expedite the development and review process of drugs that show potential in treating serious conditions, addressing unmet medical needs, and providing significant improvements in patient care.

The successful outcomes from the clinical trials and the subsequent approval of zolbetuximab-clzb mark a significant advancement in the treatment of HER2-negative gastric or gastroesophageal junction adenocarcinoma, providing new hope for patients diagnosed with these challenging forms of cancer.