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FDA Approves FoundationOne CDx as a Companion Diagnostic for Alpelisib/Fulvestrant Treatment in Breast Cancer


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On December 4, the U.S. Food and Drug Administration (FDA) approved FoundationOne CDx to be used as a companion diagnostic for alpelisib in combination with fulvestrant for the treatment of postmenopausal female patients as well as male patients with hormone receptor (HR)-positive, HER2-negative, PIK3CA-mutated, advanced or metastatic breast cancer following disease progression on or after an endocrine-based regimen.

FoundationOne CDx is the first and only FDA-approved broad comprehensive genomic profiling test for all solid tumors that incorporates multiple companion diagnostics.

In May 2019, the FDA approved alpelisib in combination with fulvestrant for the treatment of postmenopausal women and men with HR-positive, HER2-negative, PIK3CA-mutated, advanced or metastatic breast cancer following disease progression on or after an endocrine-based regimen. PIK3CA is the most commonly mutated gene in HR-positive, HER2-negative breast cancer; approximately 40% of patients with the disease type have this mutation.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
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