# FDA Approves Enhertu for HER2+ Early-Stage Breast Cancer in Neoadjuvant and Adjuvant Settings

> fda · REPORTED · 2026-05-01

The FDA approved fam-trastuzumab deruxtecan-nxki (Enhertu) for HER2-positive early-stage breast cancer in both neoadjuvant and adjuvant treatment settings in May 2026, expanding its use beyond the metastatic setting. The decision positions Enhertu as a cornerstone therapy across the full breast cancer treatment continuum.

About Enhertu — Daiichi Sankyo/AstraZeneca: Enhertu is an antibody-drug conjugate (ADC) that targets HER2-expressing cancer cells, developed by Daiichi Sankyo and co-commercialized with AstraZeneca, used across multiple breast cancer stages and subtypes.

- Company: Enhertu — Daiichi Sankyo/AstraZeneca
- Sector: oncology
- Primary source: https://novapharmanews.com/us/news/regulatory-round-up-fda-cancer-drug-approvals

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