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.
