Daiichi Sankyo, AstraZeneca granted quick review for key breast cancer indication

The U.S. FDA has accepted and granted Priority Review to Daiichi Sankyo and AstraZeneca's sBLA for Enhertu for the treatment of metastatic breast cancer that expresses low levels of the protein HER2 — an indication that could potentially represent a new standard of care for patients in this population.

The sBLA is based on data from the DESTINY-Breast04 phase 3 trial, recently presented at the American Society of Clinical Oncology Annual Meeting and simultaneously published in The New England Journal of Medicine. In the trial, Enhertu demonstrated superior and clinically meaningful efficacy in progression-free survival and overall survival.

"If approved, Enhertu will redefine how we classify and treat metastatic breast cancer, enabling patients whose tumors have lower levels of HER2 expression the opportunity to benefit from a HER2 directed therapy,” said Susan Galbraith, executive vice president, Oncology R&D, AstraZeneca.

Enhertu is a specifically engineered HER2-directed antibody-drug conjugate (ADC) being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca. It is already approved in the U.S. for patients with HER2-positive metastatic breast cancer who have previously received a HER2-targeting medicine as well as for treatment of a type of stomach cancer called gastroesophageal junction adenocarcinoma.

The PDUFA date for the newest indication is set for the fourth quarter of this year.