AstraZeneca and Daiichi Sankyo Report the US FDA’s sBLA Acceptance of Enhertu with Priority Review to Treat HR+/HER2-low Metastatic Breast Cancer
Shots:
- The sBLA for Enhertu has been accepted for priority review by the US FDA to treat HER2-low or ultralow metastatic breast cancer in patients who have received at least 1 endocrine therapy, with the decision expected during Q1’25
- The submission was based on P-III (DESTINY-Breast06) study assessing Enhertu (5.4mg/kg) vs investigator’s choice of CT (capecitabine, paclitaxel or nab-paclitaxel) to treat HR+/HER2-low or ultralow advanced or metastatic breast cancer
- Study demonstrated reduced risk of disease progression or death by 37% with mPFS of 13.2mos. vs 8.1mos. in the overall population. Similar results were seen in HER2-low & ultralow patients, with mPFS of 13.2mos. vs 8.1mos. & 13.2mos. vs 8.3mos., respectively
Ref: AstraZeneca | Image: Daiichi Sankyo & AstraZeneca
Related News:- Daiichi Sankyo’ Enhertu Gains the US FDA’s Breakthrough Therapy Designation to Treat HER2 Low or HER2 Ultralow Metastatic Breast Cancer
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
