FDA approves AstraZeneca’s Truqap plus Faslodex for breast cancer treatment
AstraZeneca has announced that the US Food and Drug Administration (FDA) has approved Truqap (capivasertib) in combination with Faslodex (fullvestrant) for the treatment of adult patients with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer with one or more biomarker alterations.
The approval was based on results from the CAPItello-291 phase 3 trial, with results having been published in The New England Journal of Medicine. The trial demonstrated that Truqap in combination with Faslodex reduced the risk of disease progression or death by 50% compared to Faslodex alone.
The safety profile of the drug remained similar to that observed in previous trials.
The regulatory submission of the drug was granted Priority Review under Project Orbis, which provides a “framework for concurrent submission and review of oncology medicines among participating international partners,” according to the company’s press release.
The drug is now under review by the relevant regulatory authorities in Australia, Brazil, Canada, Israel, Singapore, Switzerland and the UK.
Dave Fredrickson, executive vice president of the Oncology Business Unit at AstraZeneca, commented: “The rapid US approval of Truqap reinforces the important role of the PI3K/AKT pathway in HR-positive breast cancer and the critical need to test patients at the time of diagnosis, as up to 50% have tumours with these alterations. As a first-in-class medicine, this approval provides a critical new option for patients in the US with this specific type of disease and we look forward to bringing Truqap to the many breast cancer patients who can benefit across the globe.”
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