Drug Approval | February 21, 2026
FDA accepts Roche’s new drug application for Giredestrant in advanced breast cancer
The NDA filing is supported by results from the phase III evERA Breast Cancer study
The NDA filing is supported by results from the phase III evERA Breast Cancer study
The study met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in invasive disease-free survival
Importantly, the combination of giredestrant and everolimus was well tolerated
Giredestrant shows promise despite missing primary goal
At the trial’s pre-specified interim analysis, giredestrant achieved a hazard ratio of 0.70, marking a statistically significant improvement in invasive disease-free survival
Roche will unveil the primary results from the phase III evERA Breast Cancer study evaluating giredestrant
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