ENHERTU® (fam-trastuzumab deruxtecan-nxki) granted Priority Review in the US as post-neoadjuvant treatment for patients with HER2-positive early breast cancer
AstraZeneca PLC Ordinary Shares (AZN)
Last astrazeneca plc ordinary shares earnings: 2/5 04:00 pm
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Source: Business Wire
Based on DESTINY-Breast05 Phase III trial results which showed ENHERTU reduced the risk of invasive disease recurrence or death by 53% compared with T-DM1If approved, AstraZeneca and Daiichi Sankyo’s ENHERTU has the potential to become a new standard of care in this early breast cancer setting WILMINGTON, Del.--(BUSINESS WIRE)--AstraZeneca and Daiichi Sankyo’s supplemental Biologics License Application (sBLA) for ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been accepted and granted Priority Review in the US for the treatment of adult patients with HER2-positive breast cancer who have residual invasive disease after neoadjuvant HER2-targeted treatment.The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available treatment options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance. The Prescription Drug User Fee Act date,
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News
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AZN
Sec Filings
- 3/16/26 - Form 6-K
- 3/10/26 - Form 6-K
- 3/10/26 - Form 6-K
- AZN's page on the SEC website