gastroesophageal cancer
European Commission Approves BeiGene's Tevimbra, Chemo in First-Line Gastric, Esophageal Cancers
The EC considered the treatment's activity in patients with advanced, PD-L1-positive esophageal and gastric cancers in the RATIONALE-305 and -306 trials.
CHMP Recommends BeiGene's Tevimbra for First-Line PD-L1-Positive Gastric, Esophageal Cancers
The recommendation was based on results from two Phase III trials showing that Tevimbra plus chemo improved overall survival over chemo alone.
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.
The agency is considering whether to limit the indications of Keytruda, Opdivo, and Tevimbra to PD-L1-positive patients amid testing uncertainties.
FDA Expert Panel to Consider Limiting Gastric, Esophageal Cancer Immunotherapies to PD-L1 Expressors
The ODAC will weigh risk-benefit analyses from the FDA and sponsors on Keytruda, Opdivo, and Tevimbra when given with chemo in all-comers and in PD-L1-positive subgroups.