Zolbetuximab

FDA approved zolbetuximab-clzb (Vyloy) for first-line treatment of CLDN18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma, supported by phase 3 trials SPOTLIGHT and GLOW, showing improved PFS and OS. Zolbetuximab targets CLDN18.2, leading to tumor cell destruction, and synergizes with chemotherapy, offering a new biomarker-driven therapy for gastric and GEJ cancers.

Astellas Pharma Inc. received U.S. FDA approval for Vyloy (zolbetuximab-clzb), a first-in-class CLDN18.2-targeted treatment for first-line therapy in adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma. Vyloy, a CLDN18.2-directed cytolytic antibody, is used with fluoropyrimidine- and platinum-containing chemotherapy for CLDN18.2-positive tumors as determined by the VENTANA CLDN18 (43-14A) RxDx Assay. The approval follows a complete response letter in January, and Vyloy has also been approved in Japan, the U.K., the EU, and South Korea.

Astellas Pharma's Vyloy approved by FDA for advanced gastric and gastroesophageal junction cancer, first CLDN18.2-targeted therapy in the U.S., also approved in Japan, U.K., E.U., and South Korea.

FDA approves zolbetuximab-clzb (Vyloy) plus chemotherapy for HER2-negative, Claudin 18.2-positive gastric/gastroesophageal junction adenocarcinoma, supported by phase 3 SPOTLIGHT and GLOW trials showing PFS benefits.

The FDA approved zolbetuximab-clzb (Vyloy) with fluoropyrimidine- and platinum-containing chemotherapy for first-line treatment of CLDN18.2-positive, HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma. The Ventana CLDN18 (43-14A) RxDx Assay was also approved as a companion diagnostic. Efficacy was demonstrated in SPOTLIGHT and GLOW trials, showing improved progression-free and overall survival. Common serious adverse reactions included vomiting, nausea, and neutropenia.

FDA approves zolbetuximab-clzb (Vyloy) with chemotherapy for first-line treatment of HER2-negative, Claudin 18.2-positive gastric or gastroesophageal junction adenocarcinoma. Data from SPOTLIGHT and GLOW trials showed improved progression-free and overall survival.

FDA approves zolbetuximab (Vyloy) as first-line treatment for HER2-negative, CLDN18.2-positive gastric/GEJ adenocarcinoma, following resubmission after CRL. Supported by phase 3 SPOTLIGHT and GLOW studies, zolbetuximab showed improved PFS in combination with mFOLFOX6 and CAPOX.

Roche's VENTANA CLDN18 (43-14A) RxDx Assay is the first FDA-approved IHC companion diagnostic for identifying CLDN18 protein expression in gastric/GEJ adenocarcinoma, aiding in treatment eligibility for Astellas' VYLOY (zolbetuximab).