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AstraZeneca’s Enhertu granted Priority Review in the US

Susan Galbraith

If approved, AstraZeneca and Daiichi Sankyo’s Enhertu will potentially be the first HER2-directed treatment and antibody drug conjugate to receive a tumor-agnostic indication.

AstraZeneca and Daiichi Sankyo’s supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan) has been accepted and granted Priority Review in the US for the treatment of adult patients with unresectable or metastatic HER2-positive (immunohistochemistry [IHC] 3+) solid tumours who have received prior treatment or who have no satisfactory alternative treatment options.

“Today’s Priority Review for the first tumor-agnostic submission for Enhertu reflects the potential of this medicine to redefine the treatment of HER2-expressing cancers. Biomarkers for HER2 expression are already established in breast and gastric cancers, but we must now define them across tumor types. We will continue working closely with the FDA to bring this potential first tumor-agnostic HER2-targeted medicine and biomarker to patients as quickly as possible,” says Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca.

Based on data from the ongoing DESTINY-PanTumor02 Phase II trial

The sBLA is based on data from the ongoing DESTINY-PanTumor02 Phase II trial where Enhertu demonstrated clinically meaningful and durable responses leading to a clinically meaningful survival benefit in previously treated patients across HER2-expressing metastatic solid tumors, including biliary tract, bladder, cervical, endometrial, ovarian cancers, and other tumors. Data from other supporting trials in patients with HER2-positive IHC3+ tumors in the Enhertu clinical development programme, including DESTINY-Lung01 and DESTINY-CRC02, were also included in the submission.

Enhertu is a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialized by AstraZeneca and Daiichi Sankyo.

The Priority Review follows receipt of Breakthrough Therapy Designation (BTD) in the US in August 2023 for Enhertu in metastatic HER2-positive solid tumors.

Photo of Susan Galbraith: AstraZeneca