ENHERTU® Granted Priority Review in the U.S. as Post-Neoadjuvant Treatment for Patients with HER2 Positive Early Breast Cancer [Yahoo! Finance]
DAIICHI SANKYO S/ADR (DSNKY)
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Source: Yahoo! Finance
If approved, Daiichi Sankyo and AstraZeneca's ENHERTU has the potential to become a new standard of care in this early breast cancer setting TOKYO & BASKING RIDGE, N.J., March 09, 2026 BUSINESS WIRE )--Daiichi Sankyo (TSE: 4568) and AstraZeneca's (LSE/STO/NYSE: AZN) supplemental Biologics License Application (sBLA) for ENHERTU ® (fam-trastuzumab deruxtecan-nxki) has been accepted and granted Priority Review in the U.S. for the treatment of adult patients with HER2 positive (immunohistochemistry [IHC] 3+ or in-situ hybridization (ISH)+) breast cancer who have residual invasive disease after neoadjuvant HER2 targeted treatment. ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca. The U.S. Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant benefit over available
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