AstraZeneca and Daiichi Sankyo receive EU approval for Enhertu in early breast cancer
European regulators have approved the use of Enhertu as an adjuvant therapy for adult patients with HER2-positive early breast cancer following neoadjuvant treatment.
The European Commission has authorized Enhertu (trastuzumab deruxtecan) for use in patients with HER2-positive early breast cancer who have residual disease after undergoing neoadjuvant treatment. This marks the drug's first approval for curative-intent therapy within the European Union.
The regulatory decision follows the outcomes of the Phase III DESTINY-Breast05 clinical trial. Data from the study indicated that patients treated with Enhertu experienced a 53% reduction in the risk of invasive disease recurrence or death compared to those receiving T-DM1.
Enhertu, developed jointly by AstraZeneca and Daiichi Sankyo, has previously been utilized in metastatic settings. This new indication expands the clinical application of the antibody-drug conjugate into the earlier treatment phase, aiming to improve long-term outcomes for patients with residual disease post-surgery.
The approval allows the drug to be marketed across all EU member states as a monotherapy for this specific patient population, reinforcing its role in the treatment landscape for HER2-positive breast cancer.