Capivasertib in combination with Faslodex granted Priority Review in the US for patients with advanced HR-positive breast cancer

AstraZeneca's New Drug Application (NDA) for capivasertib in combination with Faslodex (fulvestrant) has been accepted and granted Priority Review in the US 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. The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance. The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is during 4Q 2023. The NDA is also being reviewed under Project Orbis, an initiative of the FDA which provides a framework for concurrent submission and review of oncology medicines among participating international partners to expedite approval for patients around the world. The NDA is based on data from the CAPItello-291 Phase III trial presented at the 2022 San Antonio Breast Cancer Symposium and recently published online in The New England Journal of Medicine. In the trial, capivasertib in combination with Faslodex demonstrated a 40% reduction in the risk of disease progression or death versus placebo plus Faslodex in the overall trial population. Although the overall survival (OS) data were immature at the time of the analysis, early data are encouraging. The trial continues to assess OS as a key secondary endpoint. The safety profile of capivasertib plus Faslodex was similar to that observed in previous trials evaluating this combination. Original source: AstraZeneca, website: http://www.astrazeneca.com, Copyright AstraZeneca 2023.
regulations and rulings; research and development; anticancer drugs; capivasertib; fulvestrant; fulvestrant; [...]