# FDA approves Enhertu for early HER2-positive breast cancer, both before and after surgery

Canonical page: https://technooptimist.io/stories/fda-approves-enhertu-for-early-her2-positive-breast-cancer-both-before-21ce340f
Date: 15 May 2026
About: [Daiichi Sankyo](https://technooptimist.io/companies/daiichi-sankyo.md) · [Enhertu](https://technooptimist.io/biotech/enhertu.md)
Original source: https://www.curetoday.com/view/fda-approves-enhertu-for-her2-positive-early-stage-breast-cancer

Enhertu moved into curative-intent treatment with two US approvals for early HER2-positive breast cancer. Before surgery (DESTINY-Breast11), Enhertu followed by standard HER2 therapy cleared the tumour in more patients than anthracycline chemotherapy. After surgery in patients with leftover cancer (DESTINY-Breast05), it beat T-DM1, the previous standard, on keeping the disease from returning.

## Key facts

- DB-11 (927 patients): pathologic complete response 67.3% vs 56.3%.
- DB-05 (1,635 patients): 3-year invasive disease-free survival 92.4% vs 83.7%.
- Adjuvant course: 5.4 mg/kg every 3 weeks for up to 14 cycles.

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