Capivasertib has been granted Priority Review by the U.S. FDA for the treatment of advanced hormone

On June 12, 2023, the New Drug Application (NDA) for capivasertib in combination with fulvestrant, submitted by AstraZeneca, has been accepted for review and granted priority review designation by the U.S. Food and Drug Administration (FDA). The application is intended for the treatment of adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer, who have experienced disease recurrence or progression during or after receiving first-line endocrine-based therapy.

Priority review designation is granted to drug applications that, if approved, would offer a significant improvement compared with existing therapies by demonstrating enhanced safety or efficacy, preventing serious diseases, or improving patient adherence, among other benefits. Under the Prescription Drug User Fee Act (PDUFA), the FDA’s target action date for making a regulatory decision is set for the fourth quarter of 2023.

This NDA is also under review under the framework of Project Orbis. Project Orbis is an FDA initiative that provides a framework for concurrent submission and review of oncology drugs among participating international partners, with the aim of accelerating global patient access to new therapies.

Breast cancer is the most common cancer worldwide, with an estimated 2.3 million new diagnoses each year. In the United States, it is projected that more than 290,000 patients will be diagnosed with breast cancer in 2023, leading to over 43,000 deaths. Over 65% of breast cancer tumors are classified as HR+ and HER2-low or HER2-. Endocrine therapy is widely used in the treatment of HR+ breast cancer, yet many patients with advanced disease develop resistance to first-line CDK4/6 inhibitors plus endocrine therapy, highlighting an urgent need for additional treatment options.

Susan Galbraith, Executive Vice President of Oncology R&D at AstraZeneca, stated: “The granting of priority review underscores the potential of capivasertib to extend the effectiveness of endocrine-based therapy for HR+ breast cancer patients who have experienced tumor progression or developed resistance to these widely used treatments. We look forward to working closely with the FDA to bring this potential first-in-class AKT inhibitor to patients as soon as possible.”