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! Financ...
AstraZeneca PLC - American Depositary Shares (AZN)
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Source: Yahoo! Finance
WILMINGTON, Del., December 22, 2025 BUSINESS WIRE )--AstraZeneca and Daiichi Sankyo's ENHERTU ® (fam-trastuzumab deruxtecan-nxki) has been granted Breakthrough Therapy Designation (BTD) in the US 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. The Food and Drug Administration (FDA) BTD accelerates the development and regulatory review of potential new medicines intended to treat a serious condition and address a significant unmet medical need. The FDA granted this BTD based on results from the DESTINY-Breast05 Phase III trial presented in a Presidential Symposium at the 2025 European Society for Medical Oncology (ESMO) Congress and subsequently published in The New England Journal of Medicine Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "For patients with residual disease after neoadjuvant
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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 cancerBusiness Wire
- Top Technology Predictions Strategic Intelligence Report 2026: AI Chip Market Dynamics Shift as Nvidia's ~90% Share Faces Pressure [Yahoo! Finance]Yahoo! Finance
- ENHERTU® Granted Breakthrough Therapy Designation in the U.S. as Post-Neoadjuvant Therapy for Patients with HER2 Positive Early Breast Cancer [Yahoo! Finance]Yahoo! Finance
- Jacobio Strikes New Cancer Drug Deal with AstraZeneca [Yahoo! Finance]Yahoo! Finance
- Jacobio Pharma Enters Global Exclusive License Agreement with AstraZeneca for Pan-KRAS Inhibitor JAB-23E73 [Yahoo! Finance]Yahoo! Finance
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