DTMT Network

The United States Food and Drug Administration (FDA) has granted Break Through Designation (BTD) for Enhertu (trastuzumab deruxtecan), an antibody-drug conjugate for the treatment of adult patients with unresectable or metastatic HER2-low breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy, AstraZeneca informed recently.

This is the fifth BTD recognition for the drug, developed and commercialised jointly by AstraZeneca and Daiichi Sankyo, including three in breast cancer and one in both lung and gastric cancers, the companies said.

The latest round of BTD recognition is based on the data of the DESTINY-Breast04 results where the drug demonstrated a significant improvement in both progression-free survival and overall survival, the companies said in an official statement.

“Today’s news is a significant validation of the potential we see for the historic DESTINY-Breast04 trial to enable a paradigm shift in how breast cancer is classified by targeting the full spectrum of HER2 expression,” Susan Galbraith, the Executive Vice President, Oncology R&D of AstraZeneca said.

“Enhertu continues to show transformative potential, and this milestone represents an important advance for patients with HER2-low metastatic breast cancer who are in urgent need of new treatment options and better outcomes,” she added.

“Historically, only patients with HER2-positive metastatic breast cancer were shown to benefit from HER2-directed therapy. DESTINY-Breast04, in which Enhertu showed a clinically meaningful survival benefit in patients with HER2-low metastatic breast cancer, is the first trial to demonstrate that selecting patients for treatment based on low expression of HER2 has the potential to change the diagnostic and treatment paradigms for these patients,” Ken Takeshita, Global Head, R&D, Daiichi Sankyo said.

“This Breakthrough Therapy Designation acknowledges the potential of Enhertu to fulfil an unmet medical need and we look forward to working closely with the FDA to bring the first HER2-directed therapy to patients with metastatic breast cancer whose tumours have lower levels of HER2 expression,” he added.