Capivasertib Plus Fulvestrant Gets Priority Review for HR-Positive Advanced Breast Cancer
The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for capivasertib in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer, following recurrence or progression on or after an endocrine-based regimen.
Capivasertib is an investigational, oral selective adenosine triphosphate (ATP)-competitive inhibitor of all 3 AKT isoforms (AKT 1/2/3). The NDA is supported by data from the phase 3 CAPItello-291 trial (ClinicalTrials.gov Identifier: NCT04305496). The study assessed the efficacy of capivasertib plus fulvestrant, an estrogen receptor antagonist, vs placebo plus fulvestrant for the treatment of patients with locally advanced (inoperable) or metastatic HR+/HER2- breast cancer following recurrence or progression on or after aromatase inhibitor therapy (N=708).
“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,” said Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca. “We look forward to working with the FDA to bring this potential first-in-class AKT inhibitor to patients as quickly as possible.”
A regulatory decision is expected in the fourth quarter of 2023. Capivasertib was previously granted Fast Track designation by the FDA in this setting for this patient population.
