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AstraZeneca PLC on Friday said that the US Food & Drug Administration approved its drug Truqap in combination with Faslodex to treat patients with an advanced form of breast cancer. The Cambridge-based pharmaceutical company said Truqap, also known as capivasertib, in combination with Faslodex, or fulvestrant, was approved in the US for patients with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer with one or more biomarker alterations, namely PIK3CA, AKT1 or PTEN. The approval by the FDA was based on phase 3 trial data published in early 2023 in the New England Journal of Medicine. The trial showed that Truqap in combination with Faslodex reduced the risk of disease progression or death by 50% compared to Faslodex alone in patients with tumours that harbour PI3K/AKT pathway biomarker alterations. Dave Fredrickson, executive vice president at AstraZeneca’s Oncology Business unit, said: ‘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.’ Breast cancer is the most common cancer, with HR-positive breast cancer being the most common subtype, with more than 65% considered HR-positive and HER2-low or HER2-negative. HER2 is a growth promoting protein that helps cancer cells grow quickly. AstraZeneca shares were 1.5% higher at 10,318.00 pence each early on Friday morning in London. Copyright 2023 Alliance News Ltd. All Rights Reserved.
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