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). Zejula — marketed by Tesaro, a subsidiary of GlaxoSmithKline (GSK) — is approved in the U.S. and Europe as a maintenance therapy for women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are responding at least partly to platinum-based chemotherapy (usually cisplatin or carboplatin). The FDA extended Zejula’s indication to include women with HRD-positive tumors who have received at least three prior lines of chemotherapy in October 2019. At the same time, it also approved myChoice CDx as a companion diagnostic test to identify advanced ovarian cancer patients who are eligible for Zejula late-line treatment. With this new application, Myriad hopes to expand myChoice CDx’s use to include the identification of women who are more likely to benefit from Zejula maintenance treatment after r
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