![]() 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, said: “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 tumour progression on, or resistance to these widely used therapies. 4 Endocrine therapies are widely used for the treatment of HR-positive breast cancer, but many patients with advanced disease develop resistance to 1st-line CDK4/6 inhibitors and endocrine therapies, underscoring the need for additional options. 3 More than 65% of breast cancer tumours are considered HR-positive and HER2-low or negative. 2 In the US, more than 290,000 patients are expected to be diagnosed in 2023, with more than 43,000 deaths. 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.īreast cancer is the most common cancer worldwide, with an estimated 2.3 million patients diagnosed each year. 1 The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is during the fourth quarter of 2023. ![]() 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. Partnerships, alliances and recognitionĪstraZeneca’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.
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