ENHERTU® Granted Breakthrough Therapy Designation in the U.S. as Post-Neoadjuvant Therapy for Patients with HER2 Positive Early Breast Cancer
DAIICHI SANKYO S/ADR (DSNKY)
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Source: Business Wire
Tenth Breakthrough Therapy Designation for Daiichi Sankyo and AstraZeneca’s ENHERTU with the latest based on DESTINY-Breast05 phase 3 trial resultsSixteenth Breakthrough Therapy Designation granted by the FDA across the oncology portfolio of Daiichi Sankyo TOKYO & BASKING RIDGE, N.J.--(BUSINESS WIRE)--ENHERTU® (trastuzumab deruxtecan) has been granted Breakthrough Therapy Designation (BTD) in the U.S. for adult patients with HER2 positive early breast cancer with residual invasive disease in the breast and/or axillary lymph nodes after neoadjuvant treatment and high risk of disease recurrence.ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN).The U.S. Food and Drug Administration (FDA) BTD is designed to accelerate the development and regulatory review of potential new medicines that are intended to treat a
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