US FDA Nods AstraZeneca's Breast Cancer Treatment

Truqap (capivasertib) by AstraZeneca has got the clearance in the United States for the treatment of adult patients with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer with one or more biomarker alterations (PIK3CA, AKT1, or PTEN). Patients must have advanced on at least one endocrine-based treatment in the metastatic setting or have suffered recurrence on or within 12 months after finishing adjuvant therapy to be eligible.The approval by the Food and Drug Administration (FDA) was based on the results from the CAPItello-291 phase III trial published earlier this year in The New England Journal of Medicine, as per pharmabiz.In patients with tumors harboring PI3K/AKT pathway biomarker alterations, Truqap plus Faslodex reduced the risk of disease progression or death by 50% compared to Faslodex alone (based on hazard ratio of 0.50, 95% confidence interval 0.38-0.65; p=<0.001; median progression-free survival (PFS) 7.3 versus 3.1 months).The most frequent disease and one of the main causes of cancer-related deaths globally is breast cancer.The most prevalent subtype of breast cancer is HR-positive, which expresses either progesterone or estrogen receptors, or both. Over 65% of tumors in this subtype are HER2-low or HER2-negative. All all, mutations in AKT1, PIK3CA, and PTEN are common and can impact as many as 50% of patients with advanced HR-positive breast cancer. Endocrine medicines are commonly employed in this scenario, although many patients acquire resistance to first-line CDK 4/6 inhibitors and estrogen receptor-targeting medications, emphasizing the need for further endocrine therapy-based choices.