The US Food and Drug Administration (FDA) has accepted and granted Priority Review to AstraZeneca’s New Drug Application (NDA) for capivasertib in combination with Faslodex (fulvestrant) for the treatment of adult patients with hormone receptor (HR)-positive, HER2-negative, locally advanced or metastatic breast cancer following recurrence or progression on or after an endocrine-based regimen.
Applications for drugs that, if approved, would provide significant enhancements over current choices by demonstrating safety or effectiveness improvements, avoiding severe diseases, or improving patient compliance are given Priority Review by the FDA. The FDA will take action on its regulatory determination within the fourth quarter of 2023, the Prescription Drug User Fee Act deadline.
The FDA’s Project Orbis, which offers a framework for concurrent submission and evaluation of cancer medications among collaborating foreign partners to accelerate approval for patients throughout the world, is also reviewing the NDA.
With an estimated 2.3 million cases diagnosed each year, breast cancer is the most prevalent disease in the world. In the US, it’s anticipated that over 290,000 individuals would receive a diagnosis in 2023, and over 43,000 people will pass away. More than 65% of breast cancer tumors are thought to be HER2-low or negative and HR-positive. Endocrine medications are frequently used to treat HR-positive breast cancer, however many patients with advanced illness develop resistance to endocrine therapy and first-line CDK4/6 inhibitors, emphasizing the need for alternative treatments.
“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. We look forward to working with the FDA to bring this potential first-in-class AKT inhibitor to patients as quickly as possible.”
– Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca
The NDA is based on information from the CAPItello-291 Phase III study, which was recently published online in The New England Journal of Medicine and presented at the 2022 San Antonio Breast Cancer Symposium.
As compared to placebo plus Faslodex, capivasertib in combination with it showed a 40% lower risk of disease progression or death in the trial’s overall population (hazard ratio [HR] of 0.60, 95% confidence interval [CI] 0.51-0.71; p=0.001; median progression-free survival (PFS) of 7.2 versus 3.6 months). Early statistics are reassuring even if the overall survival (OS) data were few at the time of study. OS is still being evaluated in the experiment as a crucial secondary goal.
Capivasertib with Faslodex had a comparable safety profile to that seen in earlier studies examining this pairing.
The FDA approved capivasertib Fast Track Designation in this scenario for this patient population in January 2023.