# FDA Decision on ENHERTU as Post-Neoadjuvant Treatment for HER2+ Early Breast Cancer

> fda · REPORTED · 2026-07-07

The FDA had a PDUFA action date of July 7, 2026 for ENHERTU (trastuzumab deruxtecan) as a post-neoadjuvant treatment for patients with HER2-positive early breast cancer, a potential major label expansion for one of oncology's top-selling ADCs.

About AstraZeneca / Daiichi Sankyo: AstraZeneca and Daiichi Sankyo co-develop ENHERTU, an antibody-drug conjugate targeting HER2 that is approved across multiple solid tumor indications and serves oncology patients globally.

- Company: AstraZeneca / Daiichi Sankyo
- Sector: biotech
- Primary source: https://www.rttnews.com/corpinfo/fdacalendar.aspx

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Source: MedFuel Intel news monitor. Verification tier: REPORTED. Informational only, not investment advice. Corrections: media@medfuelinc.com.