NEW YORK – AstraZeneca said on Monday that the US Food and Drug Administration has accepted its new drug application for the investigational AKT inhibitor capivasertib combined with Faslodex (fulvestrant) for treatment of patients with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer who have progressed after an endocrine-based treatment regimen.
The agency also granted priority review to the application and is expected to make a decision in Q4 2023. The application will be reviewed under the FDA's Project Orbis, which facilitates concurrent submission and review of cancer therapy regulatory applications among international regulatory agencies.
AstraZeneca submitted data from the Phase III CAPItello-291 trial showing that patients who received capivasertib-Faslodex saw a 40 percent reduction in the risk of disease progression or death compared to Faslodex alone and median progression-free survival of 7.2 months versus 3.6 months.
"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 tumor progression on, or resistance to these widely used therapies," Susan Galbraith, AstraZeneca's executive VP of oncology R&D, said in a statement.