18 October 2024: Astellas Gains FDA Approval for Vyloy Combination in CLDN18.2-Positive Gastric Cancer.

The FDA has approved Vyloy (zolbetuximab) as a first-line combination therapy for adults with unresectable or metastatic HER2-negative gastric or gastroesophageal adenocarcinoma, provided the tumors are CLDN18.2-positive. The approval specifies Vyloy in combination with platinum and fluoropyrimidine-based chemotherapies.

To confirm CLDN18.2 status, the FDA has also approved companion diagnostic tests from Ventana Medical and Roche.

This first-line approval is based on the results of the SPOTLIGHT and GLOW trials. In the SPOTLIGHT study, Vyloy showed a median progression-free survival (PFS) of 10.6 months compared to 8.7 months in the chemotherapy group. Similarly, in the GLOW study, Vyloy patients had a median PFS of 8.2 months compared to 6.8 months in the chemotherapy group. This approval makes Vyloy the first anti-CLDN18.2 therapy available in the US market. Astellas has already secured approval for Vyloy in Japan, the UK, and the EU.

Source: FiercePharma