Pharma Focus America

FDA Approves FoundationOne®CDx for AstraZeneca’s Truqap™ Combo in HR-Positive, HER2-Negative Advanced Breast Cancer

Tuesday, November 21, 2023

Foundation Medicine Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted approval for FoundationOne®CDx to serve as a companion diagnostic for AstraZeneca’s Truqap™ (capivasertib) in combination with Faslodex® (fulvestrant). This combination has received concurrent FDA approval 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.

Approximately 70% of advanced breast cancers are HR-positive, and up to 50% of these patients have tumors with PI3K-AKT pathway alterations. The approved FoundationOne CDx test, utilizing a tissue sample, analyzes over 300 cancer-related genes for genomic alterations in a patient’s tumor. This makes it the first FDA-approved test to identify a new subset of breast cancer patients for treatment with capivasertib. The CAPItello-291 trial demonstrated a significant improvement in progression-free survival when capivasertib was added to fulvestrant therapy for patients with HR-positive, HER2-negative PIK3CA/AKT1/PTEN-altered advanced breast cancer that had progressed after previous aromatase inhibitor therapy.

Foundation Medicine, expressed excitement about the approval, highlighting the significance of adding a new therapeutic option for HR-positive breast cancer patients. Foundation Medicine is the sole company with an FDA-approved portfolio of tissue and blood-based comprehensive genomic profiling tests. The FoundationOne CDx test currently holds over 35 companion diagnostic indications, with five specific to breast cancer.

The approval is seen as a positive development for HR-positive breast cancer patients, providing a targeted treatment option based on biomarker testing. Foundation Medicine, a global leader in companion diagnostic approvals, holds 60% of all U.S. companion diagnostic approvals for next-generation sequencing (NGS) testing. The company aims to advance precision cancer care by collaborating with partners across the cancer community and contributing to scientific excellence and regulatory leadership in molecular profiling for cancer.



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