FDA Approves AKT Inhibitor for Patients With Advanced HR-Positive Breast Cancer

Recently, AstraZeneca announced the US Food and Drug Administration (FDA) approval of a new combination therapy for the treatment of adult patients with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer with 1 or more biomarker alterations (PIK3CA, AKT1, or PTEN). Eligible patients will have progressed on at least 1 endocrine-based regimen in the metastatic setting or experienced recurrence on or within 12 months of completing adjuvant therapy.

Up to half of patients with advanced HR-positive breast cancer have PIK3CA and AKT1 mutations or PTEN alterations. Many patients with this kind of advanced breast cancer develop resistance to endocrine therapies and CDK 4/6 inhibitors, which are widely used as a first-line treatment. Once this occurs, treatment options are limited—with chemotherapy being the current standard of care—and survival rates are low. Just 30% of patients are anticipated to live beyond 5 years after diagnosis. More second-line treatment options are urgently needed to improve outcomes and reduce discontinuation rates due to adverse reactions for patients with PIK3CA, AKT1, and/or PTEN alterations.

DocWire News spoke with Ashley Gaines, vice president and franchise head of US breast cancer business at AstraZeneca, about this exciting new drug combination and the impact it stands to have in the fight against breast cancer.