ASTELLAS PHARMA

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 Astellas Pharma’s Vylov (zolbetuximab-clzb) with chemotherapy for HER2-negative, CLDN18.2-positive gastric or GEJ adenocarcinoma. Based on Phase III SPOTLIGHT and GLOW trials, Vylov showed significant improvements in PFS and OS. Common AEs included nausea, vomiting, and decreased appetite.

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.

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 Pharma (JP:4503) received FDA approval for VYLOY, a CLDN18.2-targeting treatment for advanced gastric and gastroesophageal junction cancer, based on successful SPOTLIGHT and GLOW trials. This milestone is expected to positively impact Astellas' financial forecast.

FDA approves VYLOY (zolbetuximab-clzb) for first-line treatment of CLDN18.2-positive, HER2-negative gastric/GEJ adenocarcinoma, in combination with chemotherapy. VYLOY is the first CLDN18.2-targeted therapy in the U.S., approved based on Phase 3 SPOTLIGHT and GLOW trials showing improved PFS and OS. Common side effects include nausea, vomiting, and decreased appetite.

Roche Holdings received FDA approval for its Ventana CLDN18 (43-14A) RxDx Assay, a companion diagnostic for gastric and gastroesophageal junction cancer, aiding in identifying CLDN18.2 positive tumors and potential eligibility for Astellas Pharma's Vyloy treatment.

Astellas Pharma's VYLOY (zolbetuximab-clzb) approved by FDA for first-line treatment of CLDN18.2-positive, HER2-negative advanced gastric or gastroesophageal junction cancer, in combination with chemotherapy. Roche's VENTANA CLDN18 (43-14A) RxDx Assay is the first FDA-approved IHC companion diagnostic for identifying eligible patients.