ENHERTU® Granted Breakthrough Therapy Designation in the U.S. as Post-Neoadjuvant Therapy for Patients with HER2 Positive Early Breast Cancer [Yahoo! Finance]
AstraZeneca PLC - American Depositary Shares (AZN)
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Source: Yahoo! Finance
Sixteenth Breakthrough Therapy Designation granted by the FDA across the oncology portfolio of Daiichi Sankyo TOKYO & BASKING RIDGE, N.J., December 22, 2025 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 serious condition and address a significant unmet medical need. The medicine needs to have shown encouraging preliminary
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News
- ENHERTU® (fam-trastuzumab deruxtecan-nxki) granted Breakthrough Therapy Designation in the US as post-neoadjuvant therapy for patients with HER2-positive early breast cancer [Yahoo! Finance]Yahoo! Finance
- ENHERTU® (fam-trastuzumab deruxtecan-nxki) granted Breakthrough Therapy Designation in the US as post-neoadjuvant therapy for patients with HER2-positive early breast cancerBusiness Wire
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AZN
Sec Filings
- 12/22/25 - Form 6-K
- 12/22/25 - Form 6-K
- 12/22/25 - Form 6-K
- AZN's page on the SEC website