AstraZeneca (AZ, NASDAQ: AZN) has submitted a market approval filing for its Category 1 drug candidate, capivasertib, in combination with Faslodex (fulvestrant), according to the China Center for Drug Evaluation (CDE) website. The filing has been accepted for review, marking a significant step forward in the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer. This indication targets patients who have experienced recurrence or progression following an endocrine-based regimen.
Recent Developments in the U.S.
Notably, this combination therapy was filed for approval in the United States in June of this year and has been granted priority review status. The swift progression in both markets underscores the urgency and potential of capivasertib as a treatment option for patients facing limited alternatives.
Capivasertib: A First-in-Class Inhibitor
Capivasertib is an oral, first-in-class AKT1/2/3 highly selective inhibitor that targets the PIK3/AKT signaling pathway, crucial for cancer cell growth and spread. Alterations in the PI3K/AKT pathway are commonly associated with triple-negative breast cancer (TNBC) and are linked to chemotherapy resistance, making the development of effective treatments essential.
Clinical Efficacy Demonstrated
In a Phase III clinical study, capivasertib combined with Faslodex demonstrated a 40% reduction in the risk of disease progression or death in patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer, compared to the placebo combined with Faslodex. Importantly, the study reported no significant safety concerns, reinforcing the therapeutic potential of this combination.
Conclusion: A Promising Future for Breast Cancer Treatment
The acceptance of AstraZeneca’s filing by the CDE represents a crucial milestone in the ongoing battle against breast cancer. With capivasertib showing promising clinical results and a clear mechanism of action, it is poised to become a vital addition to the treatment landscape for patients with HR-positive, HER2-negative breast cancer.-Fineline Info & Tech
