![]() 2 More than two million patients were diagnosed with breast cancer in 2020, with nearly 685,000 deaths globally. In January 2023, capivasertib was granted Fast Track Designation by the FDA in this setting for this patient population.īreast cancer is the most common cancer and is one of the leading causes of cancer-related deaths worldwide. The safety profile of capivasertib plus Faslodex was similar to that observed in previous trials evaluating this combination. The trial continues to assess OS as a key secondary endpoint. 7 Although the overall survival (OS) data were immature at the time of the analysis, early data are encouraging. 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 (based on hazard ratio of 0.60, 95% confidence interval 0.51-0.71 p=<0.001 median progression-free survival (PFS) 7.2 versus 3.6 months). 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. 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.Calls to this number will cost 13 pence per minute plus your providers access charge (only for Accor hotels). The price is only guaranteed at the time of reservation. When prices do not include all taxes, the relevant taxes (VAT and tourist/city tax) will be stated in the forthcoming stages of the reservation process. Depending on the country, these prices may not include taxes, may include VAT only or may include all taxes (VAT and tourist/city tax). Price subject to the hotel conditions, period and availability. Price observed on within the past 24 hours, for a one night stay within the next eight days, starting tomorrow. Supplementary services, breakfast and tourist/city tax are not included. *Prices start from, based on a one night stay in a standard double room for two guests.
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