Foundation Medicine, Inc., announced that the US FDA approved FoundationOne®CDx as a companion diagnostic for KEYTRUDA®, Merck’s anti-PD-1 therapy, which was also approved under accelerated approval for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high [≥10 mutations/megabase ] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.
June 17, 2020
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