The US Food and Drug Administration (FDA) has accepted AstraZeneca and Daiichi Sankyo's biologics licence application (BLA) for datopotamab deruxtecan (Dato-DXd), a new treatment option for a subset of breast cancer patients.

The application sought approval for the use of Dato-DXd in adults with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have undergone previous systemic therapy.

The Prescription Drug User Fee Act deadline for the FDA's decision will be in the first quarter of 2025.

The regulatory milestone is based on the outcomes of the TROPION-Breast01 Phase III clinical trial, which is a global, randomised, multicentre, open-label study designed to assess the efficacy and safety of Dato-DXd against selected single-agent chemotherapies.

Dato-DXd showed an improvement in progression-free survival versus the investigator's choice of chemotherapy.

While interim results for the dual primary endpoint of overall survival indicated a numerical advantage for Dato-DXd over chemotherapy, the findings were not mature at the time of the data cut-off.

Dato-DXd's safety profile was in line with earlier studies.

Datopotamab deruxtecan is a TROP2-directed DXd antibody-drug conjugate initially discovered by Daiichi Sankyo. The asset is being developed in partnership with AstraZeneca under a global agreement signed in July 2020.

Another BLA for Dato-DXd is under review in the US, based on results from the pivotal TROPION-Lung01 Phase III trial for treating adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer post systemic therapy.

AstraZeneca oncology research and development executive vice-president Susan Galbraith stated: “Despite marked progress in the treatment of HR-positive, HER2-negative breast cancer, most patients with advanced disease develop endocrine resistance and face the prospect of one or several lines of chemotherapy.

“If approved, datopotamab deruxtecan has the potential to provide these patients an efficacious and better-tolerated alternative to conventional chemotherapy.”

Last month,  the Japanese Ministry of Health, Labour and Welfare approved AstraZeneca‘s Truqap (capivasertib) plus Faslodex (fulvestrant) for a specific type of breast cancer.