FDA approves AstraZeneca's Truqap with fulvestrant for breast cancer

The Food and Drug Administration yesterday granted approval for UK pharm major AstraZeneca’s (LSE: AZN) Truqap (capivasertib) with Faslodex (fulvestrant), at the early part of the Prescription Drug User Fee Act date in the fourth quarter of 2023.

The combination therapy is authorized for the treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations, as detected by an FDA-approved test, following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.

This adds a new targeted therapy to AstraZeneca’s strong treatment offerings in breast cancer. AstraZeneca shares were 1.5% higher at 10,318.00 pence each early on Friday morning in London.