FDA Asked to Approve Test of Ovarian Cancers Likely to Respond to Zejula Maintenance Therapy

FDA Asked to Approve Test of Ovarian Cancers Likely to Respond to Zejula Maintenance Therapy
Myriad Genetics has filed a supplementary premarket approval (sPMA) application with the U.S. Food and Drug Administration (FDA) seeking approval of its myChoice CDx test to identify advanced ovarian cancer patients more likely to benefit from treatment with Zejula (niraparib) after responding to first-line platinum-based chemotherapy. MyChoice CDx is a test that determines DNA repair defects in tumors — or homologous recombination deficiency (HRD)-positive tumors — by assessing mutations in the BRCA1 and BRCA2 genes (involved in DNA repair), along with three biomarkers of genomic instability. Genomic instability refers to the high frequency of mutations within the genome. Because tumors with such defects are more dependent on other DNA repair mechanisms involving the PARP enzyme — a DNA damage sensor — they are more likely to respond to treatments, like Zejula, that block PARP activity (PARP inhibitors). Zejul
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