Zolbetuximab

Astellas Pharma receives FDA approval for Vyloy (zolbetuximab-clzb) as a first-line treatment for locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, targeting CLDN18.2. The approval is supported by positive phase 3 clinical trials Glow and Spotlight. A companion diagnostic test by Roche identifies eligible patients with 75% or more tumor cells testing positive for CLDN18.2.

Astellas Pharma’s Vyloy (zolbetuximab-clzb) approved by FDA for first-line treatment of CLDN18.2-positive, HER2-negative gastric or gastro-oesophageal junction adenocarcinoma, in combination with chemotherapy. Supported by SPOTLIGHT and GLOW trials, Vyloy shows improved progression-free and overall survival. Now approved in US, EU, UK, Japan, and South Korea.

Astellas Pharma's zolbetuximab, branded Vyloy, receives FDA approval for first-line treatment of advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma expressing CLDN18.2, offering a new targeted therapy for HER2-negative cases. Vyloy, acquired from Ganymede Pharmaceuticals, demonstrated significant improvements in progression-free and overall survival in Phase 3 trials, with common side effects including nausea, vomiting, and decreased appetite.

FDA approves Vyloy (zolbetuximab-clzb) with fluoropyrimidine- and platinum-based chemo for first-line treatment of locally advanced, unresectable or metastatic, HER2-negative gastric or gastroesophageal junction adenocarcinoma with CLDN18.2-positive tumors. Supported by phase 3 trials GLOW and SPOTLIGHT, Vyloy improved progression-free and overall survival. Common adverse events include nausea, vomiting, fatigue, and diarrhea. Vyloy is supplied as a 100 mg lyophilized powder for intravenous infusion.

Astellas Pharma secures FDA approval for Vyloy, a CLDN18.2-targeted therapy combined with chemotherapy for HER2-negative gastric or gastroesophageal junction adenocarcinoma. Vyloy is the first such therapy approved in the US, with Roche providing the companion diagnostic test. The approval is based on Phase 3 SPOTLIGHT and GLOW trials showing improved progression-free and overall survival.

The FDA approved Astellas Pharma Inc.’s VYLOY (zolbetuximab-clzb) for first-line treatment of CLDN18.2-positive, HER2-negative gastric or gastroesophageal junction adenocarcinoma. VYLOY is the first CLDN18.2-targeted therapy in the U.S., approved based on Phase 3 SPOTLIGHT and GLOW trials showing improved progression-free and overall survival. Common side effects include nausea, vomiting, and decreased appetite.

Astellas Pharma's VYLOY (zolbetuximab-clzb) gains FDA approval for advanced gastric and gastroesophageal junction cancer treatment, combined with chemotherapy. This marks the first US approval for VYLOY targeting CLDN18.2-positive tumors, identified via Roche's VENTANA CLDN18 assay. Phase III trials SPOTLIGHT and GLOW showed significant PFS and OS improvements in CLDN18.2-positive patients. VYLOY is now approved in five global markets.

Astellas secures FDA approval for Vyloy, its first-in-class CLDN18.2-targeting cancer therapy, for certain gastric cancers. Vyloy, already approved in Japan, EU, and GB, demonstrated reduced risk of disease progression or death in SPOTLIGHT and GLOW trials. The FDA also cleared a CLDN18.2 diagnostic test from Roche for patient eligibility.