Posted by Michael Wonder on 17 Nov 2023
FDA approves capivasertib with fulvestrant for breast cancer
16 November 2023 - Today, the FDA approved capivasertib (Truqap, AstraZeneca Pharmaceuticals) with fulvestrant for adult patients with hormone receptor positive, human 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.
The FDA also approved the FoundationOne CDx assay as a companion diagnostic device to identify patients with breast cancer for treatment with capivasertib with fulvestrant.
