# FDA approves Enhertu as the first treatment for HER2-low breast cancer

Canonical page: https://technooptimist.io/stories/fda-approves-enhertu-as-the-first-treatment-for-her2-low-breast-cancer-18b553b7
Date: 5 Aug 2022
About: [Daiichi Sankyo](https://technooptimist.io/companies/daiichi-sankyo.md) · [Enhertu](https://technooptimist.io/biotech/enhertu.md)
Original source: https://www.onclive.com/view/fda-approves-trastuzumab-deruxtecan-for-unresectable-or-metastatic-her2-low-breast-cancer

The FDA approved Enhertu for metastatic breast cancer with low HER2 levels, a group that had been treated as HER2-negative and had no targeted option. The DESTINY-Breast04 trial showed that the conjugate roughly doubled time to progression and added more than six months of survival versus chemotherapy. It created a new HER2-low treatment category.

## Key facts

- 557 patients randomised 2:1 to Enhertu or physician's choice of chemotherapy.
- Progression-free survival 9.9 vs 5.1 months (HR 0.50).
- Overall survival 23.4 vs 16.8 months (HR 0.64).

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