On October 23, 2019, the FDA approved the PARP inhibitor niraparib (Zejula; Tesaro) for the treatment of patients with homologous recombination deficiency (HRD)-positive advanced ovarian, fallopian tube, or primary peritoneal cancer, after ≥3 chemotherapy regimens. HRD is defined by a deleterious or suspected deleterious BRCA mutation, or a genomic instability associated with disease progression >6 months after the tumor’s response to the last platinum-based chemotherapy. On the same day, the FDA also approved the Myriad myChoice CDx test to select patients for niraparib therapy based on the HRD tumor status.
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