ENHERTU® Granted Priority Review in the U.S. for Patients with HER2 Low or HER2 Ultralow Metastatic Breast Cancer Who Have Received at Least One Line of Endocrine Therapy
DAIICHI SANKYO S/ADR (DSNKY)
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Company Research
Source: Business Wire
Based on DESTINY-Breast06 phase 3 trial which demonstrated a statistically significant and clinically meaningful progression-free survival benefit for ENHERTUIf approved, Daiichi Sankyo and AstraZeneca’s ENHERTU will be the first HER2 directed therapy and antibody drug conjugate for patients prior to receiving chemotherapy for metastatic breast cancer TOKYO & BASKING RIDGE, N.J.--(BUSINESS WIRE)--Daiichi Sankyo (TSE: 4568) and AstraZeneca's (LSE/STO/Nasdaq: 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 unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer who have received at least one endocrine therapy in the metastatic setting.ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly deve
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