The Committee backed the combination based on results from the CAPItello-281 Phase III trial, marking a key milestone in the regulatory pathway for AstraZeneca’s targeted therapy strategy in prostate cancer
The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 3 to 6 against recommending camizestrant in combination with a CDK4/6 inhibitor
The study met its primary endpoint, showing a statistically significant and clinically meaningful improvement in progression-free survival
Enhertu recently received Breakthrough Therapy Designation, accelerating development and review for this critical patient population
The FDA’s regulatory decision is expected in Q2 2026 under the Prescription Drug User Fee Act (PDUFA)
This Breakthrough Therapy Designation highlights the impressive clinical benefit of Enhertu over the current standard of care
The study focused on patients without actionable genomic alterations whose disease had progressed after prior immunotherapy and platinum-based chemotherapy
OS is a key secondary endpoint of the 948-patient study, which is evaluating whether adding AstraZeneca's PD-L1 inhibitor to standard FLOT chemotherapy
Adding one year of Imfinzi treatment to Bacillus Calmette-Guérin (BCG) induction and maintenance therapy delivered an early and sustained disease-free survival benefit vs. BCG alone
The new data highlight the potential of AstraZeneca’s innovative therapies to improve outcomes across multiple cancer types
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