gastric cancer
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.
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.
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.
Oncolytics Biotech Planning for Registration-Directed Pelareorep Trial in Advanced Breast Cancer
If it can secure the funds, Oncolytics will advance the agent into a pivotal study, based on positive data from the Phase I BRACELET-1 trial.