The Food and Drug Administration has approved Zejula for patients with advanced ovarian, fallopian tube, or primary peritoneal cancer that have been treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency-positive status.
The Food and Drug Administration (FDA) has approved Zejula (niraparib) for patients with advanced ovarian, fallopian tube or primary peritoneal cancer that have been treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD)-positive status.
A patient’s HRD status is determined by whether or not they have a deleterious or suspected deleterious BRCA mutation or if their genomic instability with disease progression is greater than six months after their last response to treatment with platinum-based chemotherapy.
The agency’s approval is based on results from the single-arm, phase 2 QUADRA trial. The researchers evaluated the PARP inhibitor in 98 women with HRD-positive advanced ovarian cancer, who demonstrated an objective response rate of 24%, all of which were partial responses. Moreover, median duration of response was 8.3 months.
In patients whose HRD status included a BRCA mutation, the objective response rate was 39% in patients with platinum sensitivity, 29% in those with platinum resistance and 19% in patients with platinum-refractory disease.
Side effects included thrombocytopenia, anemia, neutropenia, nausea, vomiting and fatigue. Reactions that warranted dose reduction or interruption occurred in 73% of patients.
At the time of data cut-off on April 11, 2018, 21 patients remained on therapy.
Zejula was initially approved by the FDA in March 2017 for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.
Check back later to learn more about how this approval will directly impact patients with HRD-positive advanced ovarian cancer.