News
Enhertu granted Priority Review in the US for patients with HER2-positive metastatic breast cancer treated with a prior anti-HER2-based regimen.- AstraZeneca + Daichi Sankyo
The application has also been granted Priority Review.The FDA grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance.
The Prescription Drug User Fee Act (PDUFA) date, the FDA action date for their regulatory decision, is during the second quarter of 2022.
Condition: Breast Cancer HER2+
Type: drug
Learning Zones
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