AstraZeneca’s Truqap plus Faslodex granted EC approval to treat advanced breast cancer
20 Jun 2024
Drug ApprovalClinical Result
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Source: PMLiVE
AstraZeneca’s (AZ) AKT inhibitor Truqap (capivasertib) and its endocrine therapy Faslodex (fulvestrant) have been approved by the European Commission (EC) as a combination treatment for a subset of adults with advanced breast cancer.
Patients eligible for the combination will have oestrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer with at least one PIK3CA, AKT1 or PTEN alteration and will have experienced disease recurrence or progression on or after an endocrine-based regimen.
The EC’s decision follows a recent recommendation from the European Medicines Agency’s and is supported by positive results from the late-stage CAPItello-291 trial, in which Truqap plus Faslodex reduced the risk of disease progression or death by 50% compared with Faslodex alone in patients with tumours harbouring PI3K, AKT pathway or PTEN alterations.
Breast cancer remains the leading cause of cancer death in Europe, where more than 550,000 new cases of the disease were diagnosed in 2022.
The growth of HR-positive breast cancer progression is often driven by ERs, and endocrine therapies that target ER-driven disease are widely used as a first-line treatment in the advanced setting and often paired with CDK4/6 inhibitors. However, resistance to these therapies develops in many patients with advanced disease, at which point treatment options are limited and survival rates are low.
“Breast cancer continues to be the leading cause of cancer-related death in Europe, and [this] news represents a significant step forward in providing an important new treatment option for patients in need of new, innovative therapies,” he said.
The authorisation comes just days after AZ’s Imfinzi (durvalumab) was approved by the US Food and Drug Administration as part of a combination therapy for a subset of endometrial cancer patients.
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