Astellas
FDA Approves Astellas' Vyloy, Chemo in First-Line CLDN18.2-Positive Gastric Cancer With Roche CDx
Vyloy is the first CLDN18.2-targeted treatment to reach the US market alongside Roche's Ventana CLDN18 RxDx Assay for identifying eligible patients.
Roche CDx Test Receives CE Marking for Use in Gastric Cancer Patients
The IHC companion diagnostic test determines CLDN18 protein expression and may help identify patients who are eligible for treatment with Vyloy.
Astellas Strikes Exclusive Option Deal for AviadoBio's Frontotemporal Dementia Gene Therapy
Astellas will make a $20 million equity investment in AviadoBio for the option to exclusively develop and commercialize AVB-101.
Astellas' Vyloy Approved in Europe as First-Line Treatment for CLDN18.2-Positive Gastric Cancer
The European Commission approval was based on two Phase III trials showing Vyloy plus chemo improved survival outcomes versus chemo alone.
UK's MHRA Approves Astellas' Vyloy for CLDN18.2-Positive Gastric Cancer
The approval is based on two trials in which Vyloy plus chemo bested chemo and placebo in advanced CLDN18.2-positive, HER2-negative gastric cancer.