--- title: "AZN :FDA Approves ENHERTU For HER2-Positive Early Breast Cancer In Neoadjuvant And Adjuvant Settings" type: "News" locale: "en" url: "https://longbridge.com/en/news/286677080.md" description: "The FDA has approved AstraZeneca and Daiichi Sankyo's ENHERTU for neoadjuvant and adjuvant treatment of HER2-positive early breast cancer, based on Phase III trial results. ENHERTU is now approved for adult patients with Stage II or III breast cancer and those with residual disease post-treatment. It is already approved in over 95 countries for metastatic breast cancer." datetime: "2026-05-17T15:50:46.000Z" locales: - [zh-CN](https://longbridge.com/zh-CN/news/286677080.md) - [en](https://longbridge.com/en/news/286677080.md) - [zh-HK](https://longbridge.com/zh-HK/news/286677080.md) --- # AZN :FDA Approves ENHERTU For HER2-Positive Early Breast Cancer In Neoadjuvant And Adjuvant Settings Add as your preferred news source on Google Add Now The US Food and Drug Administration approved AstraZeneca (AZN) and Daiichi Sankyo's ENHERTU (fam-trastuzumab deruxtecan-nxki) for both the neoadjuvant and adjuvant treatment of patients with HER2-positive early breast cancer based on results from the DESTINY-Breast11 and DESTINY-Breast05 Phase III trials, respectively. In the neoadjuvant setting, ENHERTU followed by a taxane, trastuzumab, and pertuzumab (THP) has been approved for the treatment of adult patients with HER2-positive Stage II or Stage III breast cancer. In the adjuvant setting, ENHERTU has been approved for the treatment of adult patients with HER2-positive breast cancer who have residual invasive disease following trastuzumab (with or without pertuzumab) and taxane-based treatment. ENHERTU is already approved in more than 95 countries, including the US, as a treatment for patients with HER2-positive metastatic breast cancer. ENHERTU is a specifically engineered HER2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialized by AstraZeneca and Daiichi Sankyo. For More Such Health News, visit rttnews.com For comments and feedback contact: editorial@rttnews.com Business News ### Related Stocks - [AZN.US](https://longbridge.com/en/quote/AZN.US.md) - [AZN.UK](https://longbridge.com/en/quote/AZN.UK.md) - [DSNKY.US](https://longbridge.com/en/quote/DSNKY.US.md) - [4568.JP](https://longbridge.com/en/quote/4568.JP.md) ## Related News & Research - [Enhertu® Approved in the U.S. for Two New Indications for Patients with HER2 Positive Early Breast Cancer | AZN Stock News](https://longbridge.com/en/news/286621973.md) - [FDA approves Enhertu for two HER2-positive early breast cancer indications](https://longbridge.com/en/news/286740066.md) - [AstraZeneca Scores Key FDA Wins Across Cardiovascular And Oncology Portfolios](https://longbridge.com/en/news/286801629.md) - [](https://longbridge.com/en/news/286780814.md) - [Key facts: Enhertu Cleared for Two Breast Uses; Safety Flag on AZ RSV](https://longbridge.com/en/news/286637657.md)