FDA approves niraparib for HRD-positive advanced ovarian cancer

On October 23, 2019,the Food and Drug Administration approved niraparib (ZEJULA, Tesaro, Inc.) for patients with advanced ovarian, fallopian tube, or primary peritoneal cancer treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD)-positive status. HRD is defined by either a deleterious or suspected deleterious BRCA mutation, or genomic instability in patients with disease progression greater than six months after response to the last platinum-based chemotherapy.

Efficacy was investigated in 98 patients with advanced ovarian cancer with HRD-positive tumors in the single-arm QUADRA (NCT02354586) trial. Patients were treated with three or more prior lines of chemotherapy. Patients with prior exposure to PARP inhibitors were excluded. Patients without BRCA mutations must have progressed at least six months after the last dose of platinum-based therapy. HRD-positive status was determined using the Myriad myChoice CDx as either tumor BRCA mutated (tBRCAm) (n=63) and/or a genomic instability score (GIS) ≥ 42 (n=35). All patients received 300 mg of niraparib once daily until disease progression or unacceptable toxicity.

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-niraparib-hrd-positive-advanced-ovarian-cancer