U.S. 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
Cambridge, Mass., November 20, 2023 – Foundation Medicine Inc. today announced that it has received approval from the U.S. Food and Drug Administration (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 (HR)-positive, human epidermal growth factor receptor 2 (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.
U.S. 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
Cambridge, Mass., November 20, 2023 – Foundation Medicine Inc. today announced that it has received approval from the U.S. Food and Drug Administration (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 (HR)-positive, human epidermal growth factor receptor 2 (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.
