AstraZeneca PLC and Daiichi Sankyo’s Enhertu granted Priority Review

AstraZeneca PLC (LSE:AZN) said its Enhertu treatment has been granted Priority Review by the US Food and Drug Administration (FDA) for patients with HER2-positive metastatic breast cancer treated with a prior anti-HER2-based regimen.

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

In a trial, Enhertu reduced the risk of disease progression or death by 72% versus trastuzumab emtansine (T-DM1), AstraZeneca said in a statement.

The Priority Review status was granted alongside acceptance of the supplemental Biologics License Application (sBLA) of Enhertu for the treatment of adult patients in the US with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen.

Priority Review is granted for medicines that, if approved, would offer significant improvements over available treatments.

The FDA’s regulatory decision for Enhertu is expected in the second quarter of 2022.

The sBLA is being reviewed under the Real-Time Oncology Review (RTOR) programme and Project Orbis, two FDA initiatives designed to bring effective cancer treatments to patients as early as possible.

Breast cancer is the most common cancer worldwide, with more than two million cases diagnosed in 2020, resulting in nearly 685,000 deaths globally. One in five cases of breast cancer are considered HER2-positive and despite initial treatment with trastuzumab and a taxane, patients with HER2-positive metastatic breast cancer will often experience disease progression.