MASSACHUSETTS GENERAL HOSPITAL

FDA approves Vyloy (zolbetuximab-clzb) for first-line treatment of advanced HER2-negative gastric or GEJ adenocarcinoma with CLDN18.2-positive tumors. 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.

Dopamine agonists, once first-line for restless legs syndrome (RLS), are no longer recommended due to long-term complications like augmentation. New AASM guidelines, led by John Winkelman, MD, PhD, recommend alternatives like alpha-2-delta calcium channel ligands and addressing iron deficiency.

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.

A study published in the journal Addiction suggests that weight-loss medications like Ozempic could reduce overdose and alcohol intoxication risks in people with substance use disorders. Researchers found that those taking these drugs had a 40% lower chance of overdosing and a 50% lower chance of getting drunk. Experts see potential for these medications to also reduce stigma associated with substance use, though they are not yet FDA-approved for this purpose.

Astellas announces FDA approval of VYLOY™ (zolbetuximab-clzb) for first-line treatment of advanced HER2-negative gastric/gastroesophageal junction adenocarcinoma with CLDN18.2-positive tumors, based on SPOTLIGHT and GLOW trials. VYLOY is the first CLDN18.2-targeted therapy in the U.S.

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 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.

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 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.