On December 4, 2019 Foundation Medicine, Inc. reported it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOneCDx to be used as a companion diagnostic for Piqray (alpelisib) in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen (Press release, Foundation Medicine, DEC 4, 2019, View Source [SID1234551930]). FoundationOne CDx is the first and only FDA-approved broad comprehensive genomic profiling (CGP) test for all solid tumors, including breast cancer, that incorporates multiple companion diagnostics.
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"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," stated Brian Alexander, M.D., M.P.H. Foundation Medicine’s Chief Medical Officer. "The advancements we are seeing in the treatment of breast cancer underscore the importance of harnessing genomic insights to enable personalized medicine. 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."
In May of 2019, Novartis announced that the FDA approved Piqray (alpelisib) in combination with fulvestrant for the treatment of postmenopausal women, and men, with HR+/HER2-, PIK3CA mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen metastatic breast cancer with a PIK3CA mutation 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 mutation1. Professional guidelines were updated in September of 2019 to recommend assessment for PIK3CA mutations as part of the workup of HR+/HER2- advanced or metastatic breast cancer.
Piqray is the first and only treatment specifically for patients with a PIK3CA mutation in HR+/HER2- advanced breast cancer. Foundation Medicine and Novartis have an ongoing collaboration to support the development of companion diagnostics for the Novartis oncology portfolio.
Foundation Medicine will also be presenting new data at this year’s San Antonio Breast Cancer Symposium (SABCS) highlighting the utility of comprehensive genomic profiling in cancer care, including research on PIK3CA, as well as emerging biomarkers in breast cancer.