AstraZeneca (NASDAQ:AZN) and Daiichi Sankyo moved a step closer to expanding the use of their blockbuster cancer therapy, Enhertu, into the curative-intent setting for early-stage breast cancer.
The European Medicines Agency (EMA) validated the companies’ application for Enhertu as a monotherapy for adults with HER2-positive breast cancer who still have invasive disease after receiving initial treatment and undergoing surgery.
The validation triggers a formal scientific review by the EMA’s Committee for Medicinal Products for Human Use (CHMP).
The submission is backed by data from the DESTINY-Breast05 Phase 3 trial, which showed Enhertu reduced the risk of disease recurrence or death by 53% compared to the current standard of care, Roche Holding AG’s Kadcyla (T-DM1).
The results, first presented at the ESMO 2025 Congress and published in the New England Journal of Medicine, underscore Enhertu's potential to become the preferred option for high-risk patients who fail to achieve a complete response after pre-surgical (neoadjuvant) therapy.
Enhertu, an antibody-drug conjugate (ADC) designed to deliver a high-potency payload directly to cancer cells, has already transformed the treatment of metastatic breast cancer.
The companies are currently pursuing several other regulatory paths in the EU, including a first-line metastatic indication in combination with pertuzumab and a "tumor-agnostic" label for all HER2-positive solid tumors.