# Enhertu with pertuzumab approved in the EU as first-line treatment for HER2-positive metastatic breast cancer

Canonical page: https://technooptimist.io/stories/enhertu-with-pertuzumab-approved-in-the-eu-as-first-line-treatment-for-19b118d9
Date: 1 Sep 2026
About: [Daiichi Sankyo](https://technooptimist.io/companies/daiichi-sankyo.md) · [Enhertu](https://technooptimist.io/biotech/enhertu.md)
Original source: https://www.astrazeneca.com/media-centre/press-releases/2026/enhertu-approved-in-eu-for-1l-her2-positive-mbc.html

The European Union approved Enhertu (trastuzumab deruxtecan) taken with pertuzumab as a first-line treatment for adults with unresectable or metastatic HER2-positive breast cancer, following a positive CHMP opinion. The approval rests on the DESTINY-Breast09 Phase 3 trial, which compared the combination with the standard taxane, trastuzumab and pertuzumab regimen.

## Key facts

- The trial enrolled 1,157 patients, randomised 1:1:1 to Enhertu alone, Enhertu with pertuzumab, or the standard regimen.
- Enhertu with pertuzumab reduced the risk of progression or death by 44% (hazard ratio 0.56).
- Median progression-free survival was 40.7 months with the combination vs 26.9 months with the standard regimen.
- The release says the safety profile was consistent with each drug's known profile, with no new safety concerns.
- A separate EU review covers HER2-positive breast cancer with residual disease after neoadjuvant treatment (DESTINY-Breast05).

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