FDA Approves Niraparib for HRD-positive Advanced Ovarian Cancer
On October 23, 2019, the U.S. Food and Drug Administration (FDA) 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.
The FDA also approved the Myriad myChoice CDx test
for determination of tumor HRD status to select patients for niraparib.
Read the FDA announcement
on FDA-approved test for detection of deleterious or suspected deleterious BRCA mutation and/or genomic instability for this indication.