AstraZeneca says FDA approves Enhertu for HER2-positive early breast cancer indications
PUBT·05/18/2026 06:09:35
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- AstraZeneca’s Enhertu won FDA clearance for two new HER2-positive early breast cancer uses, expanding the drug into curative-intent treatment.
- The label now covers neoadjuvant therapy in Stage II-III disease using Enhertu followed by THP, based on the Phase III DESTINY-Breast11 trial.
- It also covers adjuvant treatment for patients with residual invasive disease post-surgery, based on Phase III DESTINY-Breast05 data.
- The approvals trigger USD 155 million in milestone payments from AstraZeneca to Daiichi Sankyo.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. AstraZeneca plc published the original content used to generate this news brief on May 18, 2026, and is solely responsible for the information contained therein.
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