Zolbetuximab

FDA approved zolbetuximab (Vyloy) with chemotherapy for first-line treatment of advanced HER2-negative gastric or gastroesophageal junction adenocarcinoma. Approval based on phase III SPOTLIGHT and GLOW trials showing improved progression-free and overall survival. Most common serious adverse reactions include vomiting, nausea, and neutropenia.

FDA approved Astellas’ Vyloy for gastric cancer, available in 6-12 business days at $1600/100mg vial. Vyloy, first targeted therapy for specific protein family in gastric cancers, was previously approved in Japan and UK. Roche’s companion diagnostic test also approved to identify eligible patients.

FDA approves Vyloy (zolbetuximab-clzb) for first-line treatment of HER2-negative gastric or gastroesophageal junction adenocarcinoma, in combination with fluoropyrimidine- and platinum-containing chemotherapy. Vyloy, developed by Astellas, targets Claudin 18.2, leading to cancer cell death via immune system pathways. Clinical trials SPOTLIGHT and GLOW showed improved progression-free and overall survival. Astellas offers a copay program for Vyloy, with an annual limit of $25,000.

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.

FDA approves Vyloy with chemotherapy for first-line treatment of HER2-negative, CLDN18.2-positive gastric or GEJ adenocarcinoma, based on SPOTLIGHT and GLOW trials showing improved survival rates.

FDA approves zolbetuximab-clzb plus chemotherapy for HER2-negative, CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma. Phase 3 trials SPOTLIGHT and GLOW showed significant improvements in progression-free survival (PFS) and overall survival (OS) with zolbetuximab regimen compared to standard care, with similar treatment-related adverse events.

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.