Astrazeneca's Enhertu gains EU recommendation for breast cancer

• Enhertu received a positive CHMP opinion recommending EU approval for early-stage HER2-positive breast cancer with residual invasive disease.
• The recommendation is based on Phase 3 DESTINY-Breast05 results showing a 53% reduction in recurrence or death risk compared with T-DM1.
• The European Commission will review the recommendation and make the final marketing authorization decision.

AstraZeneca (NASDAQ:AZN) and Daiichi Sankyo received a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for Enhertu (trastuzumab deruxtecan) in the adjuvant treatment of adults with resected HER2-positive breast cancer.

The recommendation covers patients with residual invasive disease after neoadjuvant taxane-based and HER2-targeted treatment and is based on results from the Phase 3 DESTINY-Breast05 trial.

“This positive CHMP opinion underscores the potential role of Enhertu in the curative-intent setting where it is critical to maximize the potential for sustained long-term outcomes,” said John Tsai, M.D., Global Head of R&D at Daiichi Sankyo.

In DESTINY-Breast05, Enhertu reduced the risk of invasive disease recurrence or death by 53% compared with T-DM1, with three-year invasive disease-free survival rates of 92.4% for Enhertu and 83.7% for T-DM1.

Enhertu is a HER2-directed antibody drug conjugate developed by Daiichi Sankyo and jointly developed and commercialized with AstraZeneca across multiple cancer indications.

The European Commission will review the CHMP opinion and decide on marketing authorization in the European Union, while the safety profile remained consistent with previously reported data from the DESTINY-Breast05 trial.