Companion Diagnostic for Retevmo Approved

FDA has approved a Foundation Medicine PMA for its FoundationOne CDx to be used as a companion diagnostic for Eli Lilly’s Retevmo (selpercatinib), which was approved for treating adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options. “Using a tissue sample, FoundationOne CDx analyzes more than 300 cancer-related genes for genomic alterations in a patient’s tumor, which allows a tailored treatment approach and will determine if Retevmo is an appropriate treatment option for patients with RET gene fusions, which occur in less than two percent of solid tumors,” the company says. The device has over 30 companion diagnostic indications, including lung, breast, prostate, colon, and other solid malignancies, it adds.