Posted by Michael Wonder on 20 Nov 2023
US FDA approves FoundationOne CDx as a companion diagnostic for AstraZeneca’s Truqap (capivasertib) in combination with Faslodex (fulvestrant) to identify patients with HR positive, HER2 negative advanced breast cancer
20 November 2023 - Foundation Medicine today announced that it has received approval from the US FDA for FoundationOne CDx to be used as a companion diagnostic for AstraZeneca’s Truqap (capivasertib) in combination with Faslodex (fulvestrant) which has been contemporaneously approved for the treatment of adult patients with hormone receptor positive, HER2 negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.
Approximately 70% of advanced breast cancers are hormone receptor positive, and PI3K-AKT pathway alterations occur in the tumours of up to 50% of these hormone receptor positive patients.
