Biopharmaceutical company AstraZeneca plc (STO:AZN) (LON:AZN) (Nasdaq:AZN) announced on Friday that TRUQAP (capivasertib) in combination with fulvestrant has secured approval in the United States for treating adult patients with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer, displaying biomarker alterations (PIK3CA, AKT1 or PTEN).

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 US Food and Drug Administration (FDA) was based on findings from the CAPItello-291 Phase III trial, which revealed a 50% risk reduction in disease progression or death for TRUQAP combined with fulvestrant, compared to fulvestrant alone, in patients with PI3K/AKT/PTEN pathway biomarker alterations.

Concurrently, the FDA approved a companion diagnostic test to identify relevant alterations (PIK3CA, AKT1 and PTEN).

TRUQAP plus fulvestrant is undergoing international regulatory scrutiny through Project Orbis, with reviews in Australia, Brazil, Canada, Israel, Singapore, Switzerland and the UK. Regulatory assessments are also underway in China, the European Union, Japan and other nations.