FDA has approved FoundationOne CDx, from Foundation Medicine, Cambridge, Mass, for use as a companion diagnostic for Piqray (alpelisib) in combination with fulvestrant for the treatment of men and postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2–), PIK3CA-mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen.
FoundationOne CDx is the only FDA-approved comprehensive genomic profiling test for all solid tumors, including breast cancer, that incorporates multiple companion diagnostics.
“Foundation Medicine is proud to achieve another FDA approval for FoundationOne CDx as a companion diagnostic for Piqray for the treatment of metastatic breast cancer with a PIK3CA mutation,” says Brian Alexander, MD, MPH, chief medical officer at Foundation Medicine. “The advancements we are seeing in the treatment of breast cancer underscore the importance of harnessing genomic insights to enable personalized medicine.”
FoundationOne CDx is a next-generation sequencing based in vitro diagnostic for the detection of genetic substitutions, insertion and deletions, and copy number variations in 324 genes and select gene rearrangements, as well as genomic signatures, including microsatellite instability and tumor mutational burden. The test is performed on DNA isolated from formalin-fixed, paraffin-embedded tumor tissue specimens. FoundationOne CDx is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling.
“Taking a comprehensive and validated approach to genomic testing is critical for patients with metastatic breast cancer, to help physicians determine a treatment roadmap upfront that may include FDA-approved targeted therapies like Piqray,” says Alexander.
In May 2019, FDA approved Piqray (alpelisib) in combination with fulvestrant for the treatment of men and postmenopausal women with HR+/HER2–, PIK3CA-mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen.
PIK3CA is the most commonly mutated gene in HR+/HER2– breast cancer; approximately 40% of patients living with HR+/HER2– breast cancer have this mutation. Professional guidelines were updated in September 2019 to recommend assessment for PIK3CA mutations as part of the workup of HR+/HER2– advanced or metastatic breast cancer. Piqray is the only treatment specifically for patients with a PIK3CA mutation in HR+/HER2– advanced breast cancer.
For more information, visit Foundation Medicine.