HER2 Biomarkers
AstraZeneca, Daiichi Sankyo's Enhertu BLA in HER2-Low, Ultralow Breast Cancer Gets FDA Priority Review
The FDA expects to issue a decision in the first quarter of 2025, and if the agency grants approval, it will expand the biomarker-eligible population for the drug.
NICE Declines to Recommend Menarini's Orserdu in ESR1-Mutant Breast Cancer in England
In a draft guidance, the institute did not recommend Orserdu, but is collecting additional data and public comments on this preliminary decision.
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.
AstraZeneca, Daiichi Sankyo Hoping to Sway FDA of Dato-DXd Benefit Despite Overall Survival Miss
Despite showing a progression-free survival benefit, the antibody-drug conjugate did not improve overall survival in HR-positive, HER2-negative or -low breast cancer.
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.