AstraZeneca’s breast cancer drug given Priority Review by FDA

James Spargo | June 13, 2023 | News story | Business Services AstraZeneca, FDA, Oncology, breast cancer 

UK-based pharmaceutical company AstraZeneca has announced that the US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) and granted Priority Review for its hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)- negative, locally advanced or metastatic breast cancer treatment.

The review is for capivasertib in combination with Faslodex (fulvestrant). Capivasertib is a potent, adenosine triphosphate (ATP)-competitive inhibitor of all three AKT isoforms (AKT 1/2/3) and is being tested in the CAPItello-291 phase 3, double-blind, randomised trial for tumours harbouring alterations in the AKT pathway and in tumours reliant on signalling via this pathway. The FDA’s decision was based on data from the trial.

CAPItello-291 enrolled 708 patients with histologically confirmed HR-positive, HER2-low or negative breast cancer, whose disease has recurred or progressed during or after aromatase inhibitor therapy, with or without a CDK4/6 inhibitor, and up to one line of chemotherapy for advanced disease. The trial has two primary endpoints; progression-free survival (PFS) in the overall patient population, and PFS in patients whose tumours have qualifying alterations in the AKT pathway (PIK3CA, AKT1 or PTEN genes).

Susan Galbraith, executive vice president of Oncology R&D at AstraZeneca, said: “This Priority Review decision underscores the potential of capivasertib to extend the effectiveness of endocrine-based treatment approaches for patients with HR-positive breast cancer who experience tumour progression on, or resistance to, these widely used therapies. We look forward to working with the FDA to bring this potential first-in-class AKT inhibitor to patients as quickly as possible.”

James Spargo

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