FDA Approves FoundationOne CDx as Companion Diagnostic for Alpelisib

December 5, 2019

The FDA approved FoundationOne CDx as a companion diagnostic for alpelisib in combination with fulvestrant for the treatment of men and postmenopausal women with HR+/HER2- PIK3CA-mutated breast cancer.

The FDA approved FoundationOne CDx (F1CDx) to be used as a companion diagnostic (CDx) for alpelisib (Piqray) in combination with fulvestrant for the treatment of men and postmenopausal women 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, according to Foundation Medicine, the device’s developer.1

The first FDA-approved broad CDx that is clinically and analytically validated for solid tumors, F1CDx has national coverage for qualifying Medicare and Medicare Advantage patients across all solid tumors.

“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,” Brian Alexander, MD, MPH, Foundation Medicine’s chief medical officer, said in a press release.

F1CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion, and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements, along with genomic structures including microsatellite instability and tumor mutational burden using DNA isolated from formalin-fixed paraffin embedded tumor tissue specimens.

The CDx is designed as a companion diagnostic to identify patients who could benefit from treatment with certain targeted therapies. Moreover, F1CDx is intended to provide tumor mutation profiling for patients with solid malignant neoplasms.

In May 2019, the FDA approved alpelisib, the only treatment currently available to help treat PIK3CA mutations in HR+/HER2- advanced or metastatic breast cancer. PIK3CA is the most commonly mutated gene in HR+/HER2-, with approximately 40% of patients having this mutation.

Approval for alpelisib was based on SOLAR-1, a phase III, randomized, double-blind, placebo-controlled trial in a cohort of 572 men and postmenopausal women with HR+/HER2- advanced or metastatic breast cancer whose disease had progressed on or after receiving an aromatase inhibitor, according to the FDA.2

The recommended dose of alpelisib is 300 mg (two 150 mg tablets) taken orally, once daily, with food. The recommended dose of fulvestrant, when given with alpelisib, is 500 mg administered intramuscularly on days 1, 15, and 29, and once monthly thereafter.

Foundation Medicine will be presenting new data at the San Antonio Breast Cancer Symposium (SABCS) this year, highlighting their research in genomic profiling, PIK3CA, and biomarkers in breast cancer.

References:
Foundation Medicine Expands Indication for FoundationOne®CDx as a Companion Diagnostic for Piqray® (alpelisib) [news release]. Cambridge, Massachusetts. Published December 4, 2019. foundationmedicine.com/press-releases/a9f8e620-9997-43e1-a5c9-94c79616f07f. Accessed December 5, 2019.