ENHERTU Plus Pertuzumab Granted U.S. Breakthrough Therapy Designation for First-Line Treatment of HER2 Positive Metastatic Breast Cancer
Friday, July 18, 2025
ENHERTU® (fam-trastuzumab deruxtecan-nxki), when used in combination with pertuzumab, has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the first-line treatment of adults with unresectable or metastatic HER2 positive breast cancer.
ENHERTU is a targeted antibody-drug conjugate developed by Daiichi Sankyo and jointly developed and commercialised with AstraZeneca. The BTD recognises therapies that treat serious conditions and meet significant unmet medical needs, based on early clinical evidence showing substantial improvement over existing treatments.
This designation is supported by results from the phase 3 DESTINY-Breast09 trial, presented during a late-breaking session at the 2025 Annual Meeting of the American Society of Clinical Oncology (ASCO).
Data from the study showed that the ENHERTU and pertuzumab combination achieved a median progression-free survival of over three years, offering a notable improvement compared to the current standard of care, which has remained largely unchanged for over ten years.
This is the fifth BTD granted to ENHERTU for breast cancer and the ninth overall. Previous recognitions include designations for both HER2 positive and HER2 low metastatic breast cancers. ENHERTU has also been granted BTDs for other HER2-driven tumours, including metastatic colorectal cancer, non-small cell lung cancer, and gastric cancer. In total, this marks the thirteenth BTD received across Daiichi Sankyo’s oncology portfolio.
DESTINY-Breast09 is a global phase 3 trial designed to assess the safety and effectiveness of ENHERTU alone or with pertuzumab compared to the standard THP regimen (a combination of a taxane, trastuzumab and pertuzumab) as a first-line treatment for HER2 positive metastatic breast cancer.
In the trial, patients were randomly assigned to one of three groups: ENHERTU alone with a matching placebo, ENHERTU combined with pertuzumab, or standard THP treatment. The study considered factors such as patients' previous treatments, hormone receptor status, and presence of PIK3CA gene mutations.
The primary goal is to measure progression-free survival (PFS) through an independent central review. Secondary outcomes include overall survival, response rates, duration of response, drug activity in the body, and safety. The part of the trial comparing ENHERTU alone with THP is still ongoing and remains blinded to both patients and researchers until final results are available.
Source: businesswire.com
