Turn on cookies to sign in
Signing in saves your progress to your Curie account. We can only do that with cookies on — turn them on to continue.
The European Commission has approved trastuzumab deruxtecan (T-DXd; Enhertu) as adjuvant therapy for HER2-positive early breast cancer patients with residual invasive disease after neoadjuvant treatment — marking its first EU approval in a curative-intent setting. The decision is backed by DESTINY-Breast05 trial data showing T-DXd cut the risk of recurrence or death by 53% vs. the current standard of care, T-DM1. The drug is now approved across the US, EU, China, and several other countries.
The European Commission has officially approved trastuzumab deruxtecan (T-DXd; Enhertu) as a single-agent adjuvant therapy for adult patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant treatment with a taxane and HER2-directed therapy. This marks T-DXd's first EU approval in a curative-intent setting and follows a positive recommendation from the EMA's CHMP. China's NMPA also granted approval earlier in October 2026, adding to existing approvals in the US, Brazil, Canada, and India.
The approval is grounded in data from the phase 3 DESTINY-Breast05 trial, which compared T-DXd head-to-head with ado-trastuzumab emtansine (T-DM1), the previous standard of care. T-DXd demonstrated a striking efficacy advantage, with consistent benefits seen across key patient subgroups.
By the Numbers:
Why it matters: For HER2+ breast cancer patients who don't achieve a complete response after neoadjuvant therapy — a group at significantly higher recurrence risk — T-DXd now offers a more effective post-surgery option than T-DM1, potentially raising the bar for cure in this setting globally.
