# Enhertu (T-DXd) Approved for HER2-Positive Early-Stage Breast Cancer in Two New Indications

> fda · REPORTED · 2026-05-15

The FDA approved trastuzumab deruxtecan for two separate neoadjuvant and adjuvant indications in adults with HER2-positive early-stage breast cancer, supported by the DESTINY-Breast11 and DESTINY-Breast05 trials. A separate supplemental BLA for patients with residual invasive disease after neoadjuvant therapy was also under priority review with an August 2 goal date.

About AstraZeneca / Daiichi Sankyo: Enhertu (trastuzumab deruxtecan, T-DXd) is an antibody-drug conjugate developed by AstraZeneca and Daiichi Sankyo targeting HER2-expressing cancer cells.

- Company: AstraZeneca / Daiichi Sankyo
- Sector: oncology
- Primary source: https://www.targetedonc.com/view/q3-2026-oncology-outlook-key-fda-decisions-to-watch

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