AstraZeneca announces approval of Truqap plus Faslodex in the U.S.

AstraZeneca’s Truqap in combination with Faslodex has been approved in the US for the treatment of adult patients with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer with one or more biomarker alterations. Eligible patients will have progressed on at least one endocrine-based regimen in the metastatic setting or experienced recurrence on or within 12 months of completing adjuvant therapy. The approval by the Food and Drug Administration was based on the results from the CAPItello-291 Phase III trial published earlier this year in The New England Journal of Medicine. In the trial, Truqap in combination with Faslodex reduced the risk of disease progression or death by 50% versus Faslodex alone in patients with tumours harbouring PI3K/AKT pathway biomarker alterations. Concurrently with this approval, the FDA also approved a companion diagnostic test to detect relevant alterations. The US regulatory submission was granted Priority Review and reviewed under Project Orbis, which provides a framework for concurrent submission and review of oncology medicines among participating international partners. As part of Project Orbis, Truqap plus Faslodex is also under review by regulatory authorities in Australia, Brazil, Canada, Israel, Singapore, Switzerland and the UK. Following this approval in the US, Astex Therapeutics is eligible to receive a milestone payment from AstraZeneca on first commercial sale of the drug in the US as well as royalties on future sales in line with the agreement between the two companies.