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Daiichi Sankyo's Application for Enhertu in HER2-Low Breast Cancer to Commence European Review

NEW YORK – Daiichi Sankyo said Wednesday that the European Medicines Agency confirmed its application for Enhertu (trastuzumab deruxtecan) as a treatment for HER2-low breast cancer is complete and will begin review by the Committee for Medicinal Products for Human Use.

The application is based on results of a Phase III trial showing that patients with HER2-low metastatic breast cancer receiving Enhertu had a median progression-free survival of 9.9 months compared to those receiving their physician's choice of treatment. Overall survival was 23.4 months for the Enhertu group versus 16.8 months for the physician's choice group.

To qualify for the trial, patients had to be diagnosed with HER2-low unresectable or metastatic breast cancer. For these purposes, low expression of HER2 was defined as a score of 1+ on immunohistochemical analysis, or IHC 2+ with negative results for HER2 gene amplification by in situ hybridization.

Enhertu, also known as T-Dx, is an antibody-drug conjugate designed to target HER2. It was developed and commercialized jointly by Daiichi Sankyo and AstraZeneca.

"Trastuzumab deruxtecan is the first HER2-directed therapy to demonstrate a survival benefit in patients with HER2-low metastatic breast cancer. We now have the potential to redefine how we classify and treat approximately half of all metastatic breast cancers," Daiichi Sankyo Senior VP of Oncology Development Gilles Gallant said in a statement. "In addition to the ongoing review of two other applications for the treatment of patients with HER2 positive metastatic breast cancer or gastric cancer in Europe, we are pleased to have received this third validation for HER2-low metastatic breast cancer with the goal of bringing trastuzumab deruxtecan to as many eligible patients with HER2 targetable cancers as possible."