ASTELLAS PHARMA EUROPE LTD.

Alphina Therapeutics appoints Nick Galli as CEO, with Barbara S. Fox becoming board chair. Galli brings 20 years of experience in strategy and business development, aiming to advance Alphina's NAMPT inhibitor program for solid tumor treatments.

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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 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.

The article discusses the importance of SSR (Server-Side Rendering) in modern web development, emphasizing its role in improving performance and user experience.

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.