AZN, Daiichi's Enhertu Gets FDA Nod for First-Line Breast Cancer [Yahoo! Finance]
AstraZeneca PLC - American Depositary Shares (AZN)
Last astrazeneca plc - american depositary shares earnings: 2/5 04:00 pm
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Source: Yahoo! Finance
Enhertu (trastuzumab deruxtecan) is now approved in combination with Roche's Perjeta (pertuzumab) as first-line treatment for adult patients with unresectable or metastatic HER2-positive breast cancer in the United States. This approval is based on data from the phase III DESTINY-Breast09 study, followed by a priority review and Breakthrough Therapy designation by the FDA. The regulatory application for Enhertu was reviewed under the FDA's real-time oncology review (RTOR) program. Enhertu is already approved for the second-line treatment of patients with HER2-positive breast cancer in more than 85 countries, including the United States. It is also approved in HER2-targeted indications for lung and gastric cancers. Following the approval of Enhertu for first-line use in breast cancer, AstraZeneca is entitled to pay Daiichi Sankyo $150 million as a milestone payment. Over the past year, AZN's shares have surged 36.3% compared with the industry's 12.1% rise. Image Source: Zacks
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News
- Compugen rises on royalty deal with AstraZeneca [Seeking Alpha]Seeking Alpha
- Jackson Choy Joins Match Health Collective as Co-Founder and President of Pulse Health Sciences [Yahoo! Finance]Yahoo! Finance
- High-value oncology deals drive China's drug licensing boom [Yahoo! Finance]Yahoo! Finance
- ENHERTU® (fam-trastuzumab deruxtecan-nxki) plus pertuzumab approved in the US as first new treatment in a decade for the 1st-line treatment of patients with HER2-positive metastatic breast cancer [Yahoo! Finance]Yahoo! Finance
- ENHERTU® (fam-trastuzumab deruxtecan-nxki) plus pertuzumab approved in the US as first new treatment in a decade for the 1st-line treatment of patients with HER2-positive metastatic breast cancerBusiness Wire
AZN
Sec Filings
- 12/16/25 - Form 6-K
- 12/16/25 - Form 6-K
- 12/4/25 - Form 6-K
- AZN's page on the SEC website