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

Original from: Foundation Medicine

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.

Approximately 70% of advanced breast cancers are HR-positive, and PI3K-AKT pathway alterations occur in the tumors of up to 50% of these HR-positive patients. Endocrine therapy, the mainstay first line treatment in combination with CDK4/6 inhibition, does not stop disease progression for most of these patients and treatment thereafter remains a clinical challenge. CAPItello-291, a double-blind, phase 3, randomized trial showed that the addition of capivasertib to fulvestrant therapy resulted in a significant improvement in progression-free survival among patients with HR-positive, HER2-negative PIK3CA/AKT1/PTEN-altered advanced breast cancer whose disease had progressed during or after previous aromatase inhibitor therapy with or without a CDK4/6 inhibitor. FoundationOne CDx will be the first FDA-approved test to identify this new, prevalent subset of breast cancer patients for treatment with capivasertib.

“We are thrilled to see an additional therapeutic option approved to help treat the high number of HR-positive breast cancer patients,” said Troy Schurr, Chief Biopharma Business Officer at Foundation Medicine. “This companion diagnostic approval adds to the growing utility of Foundation Medicine’s high-quality diagnostic test portfolio in treating advanced breast cancer.”

Foundation Medicine is the only company with an FDA-approved portfolio of tissue and blood-based comprehensive genomic profiling tests. Using a tissue sample, the FDA-approved FoundationOne CDx test analyzes more than 300 cancer-related genes for genomic alterations in a patient’s tumor. The test currently has over 35 companion diagnostic indications, five of which are in breast cancer.

“The prevalence of HR-positive breast cancer means the introduction of new targeted treatment options for this patient population will have an exponential impact,” said Shehzin Tietjen, Associate Director, Corporate Relations at Living Beyond Breast Cancer. “Biomarker testing is such an important component of getting patients on the right therapy for their specific cancer, and we’re encouraged to see additional companion diagnostic indications being approved to help increase patient access to precision medicine.”

Foundation Medicine is the global leader in companion diagnostic approvals. The company has 60% of all U.S. companion diagnostic approvals for next generation sequencing (NGS) testing.

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Source: 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