06:40 AM EDT, 10/01/2024 (MT Newswires) -- AstraZeneca ( AZN ) said Tuesday that its supplemental biologics license application for Enhertu has been accepted and given priority review in the US for the treatment of adult patients with a specific type of breast cancer.

A regulatory decision from the US Food and Drug Administration is expected on Feb. 1.

Enhertu is being jointly developed and commercialized by AstraZeneca ( AZN ) and Daiichi Sankyo, which discovered the antibody drug conjugate.

The application is based on data from a late-stage clinical trial in which Enhertu reduced the risk of disease progression or death by 37% by blinded independent central review versus chemotherapy.

The study also found that Enhertu had a median progression-free survival of 13.2 months versus 8.1 months with chemotherapy, the company said.

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