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FDA Expands Approval of Companion Diagnostic for Olaparib in Prostate Cancer


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On November 9, the U.S. Food and Drug Administration (FDA) approved FoundationOne Liquid CDx to be used as a companion diagnostic for olaparib. As a companion diagnostic, FoundationOne Liquid CDx will use a blood-based biopsy to identify patients with BRCA1, BRCA2, and/or ATM alterations and metastatic castration-resistant prostate cancer who may be appropriate for treatment with olaparib.

Prostate cancer is the second-most common cancer in men globally; despite progress made toward new treatment modalities, the mortality rate for this condition remains high. Of critical importance is ensuring patients with metastatic prostate cancer receive comprehensive genomic profiling via liquid- or tissue-based biopsies to determine eligibility for new targeted treatment options. Foundation Medicine’s tissue-based comprehensive genomic profiling test, FoundationOne CDx, was approved as a companion diagnostic for olaparib in May 2020.

FoundationOne Liquid CDx is a qualitative next-generation sequencing–based in vitro diagnostic test for prescription use only that uses targeted high-throughput hybridization-based capture technology to analyze 324 genes utilizing circulating cell-free DNA isolated from plasma derived from anticoagulated peripheral whole blood of patients with advanced cancer. The test is FDA-approved to report short variants in over 300 genes and is a companion diagnostic to identify patients who may benefit from treatment with specific therapies in accordance with the approved therapeutic product labeling.

Olaparib was approved in May 2020 for patients with metastatic castration-resistant prostate cancer with mutations in homologous recombination repair genes based on results from the PROfound study.

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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