FDA Approves NGS Panel for Gene Mutation Detection in Metastatic Colorectal Cancer

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The panel is the first FDA-approved NGS test for colorectal cancer that can detect multiple gene mutations in a single test.
The panel is the first FDA-approved NGS test for colorectal cancer that can detect multiple gene mutations in a single test.

The US Food and Drug Administration (FDA) granted marketing approval to the Praxis Extended RAS Panel, a next generation sequencing (NGS) test used to determine the eligibility of patients with metastatic colorectal cancer (mCRC) for panitumumab treatment.1

The panel is used to identify genetic mutations in mCRC tumor samples obtained from patients.

Prior studies demonstrated that patients without KRAS or NRAS mutations treated with panitumumab saw increases in overall survival and progression-free survival.

The panel is able to detect up to 56 genetic mutations in RAS genes (KRAS exons 2, 3, and 4 and NRAS exons 2, 3, and 4) in tumor tissue samples obtained from patients with mCRC.

It is not recommended that patients receive panitumumab if any of the target mutations are present in the samples; if no mutations are detected panitumumab therapy may be considered.

The product labeling for panitumumab was updated to reflect the indication for panitumumab and intended use for the Praxis Extended RAS Panel.

RELATED: Three-month XELOX Regimen May Be Non-inferior to 6-month Regimen in Colorectal Cancer

The panel is the first FDA-approved NGS test for colorectal cancer that can detect multiple gene mutations in a single test. 

Reference

  1. FDA granted marketing approval to the praxis extended RAS panel [news release]. Silver Spring, MD: US Food and Drug Administration; Updated July 5, 2017. https://www.fda.gov/Drugs/InformationOnDrugs/ ApprovedDrugs/ucm565785.htm. Accessed July 5, 2017.

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