AstraZeneca's drug, Truqap (capivasertib), when used in conjunction with Faslodex (fulvestrant), has received a recommendation for approval within the European Union. The treatment is intended for adult patients with ER-positive, HER2-negative advanced or metastatic breast cancer that displays one or more PIK3CA, AKT1, or PTEN-alterations. This specific patient group has faced recurrence or progression of the disease after an endocrine-based regimen.
A Committee for Medicinal Products for Human Use, which is a part of the European Medicines Agency, based its endorsement on findings from the CAPItello-291 trial. The trial demonstrated a 50% reduction in the risk of disease progression or death with the Truqap and Faslodex combination compared to the standard Faslodex treatment.
The company confirmed that the product applications are under review in a number of countries including China. Existing approvals for the Truqap and Faslodex combination exist in Japan, the US, and other nations. These decisions were founded on the same CAPItello-291 trial results.
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