Posted on April 3rd, 2017 by
Zejula (Niraparib) has been approved by the US Food and Drug Administration (FDA) for use as maintenance therapy in patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal who are in complete or partial response to platinum-based chemotherapy.
Niraparib is a poly ADP-ribose polymerase (PARP) inhibitor, but unlike other drugs in this class, it is active both in patients with and those without BRCA mutations.
The FDA approval is based on results from a clinical trial known as NOVA, which demonstrated a significant delay in the time to cancer progression for patients in remission treated with Zejula.
The trial was conducted in 553 patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who had received at least two prior treatments of platinum-based chemotherapy and were in a complete or partial response to the most recent chemotherapy treatment.
Patients in the NOVA trial were divided into two groups – those with germline BRCA mutation (n = 203) and those without (n = 350). The results showed a significant improvement in patients with or without the germline BRCA mutation.
In the patients with a germline BRCA mutation, the time to delay in cancer progression for those taking Zejula was 21 months compared with only 5.5 months for those not receiving the drug. The benefit was less for patients without a mutation; 9.3 months compared with 3.9 months for those not taking Zejula.
Reference: Mansoor R. Mirza, M.D et. al. Niraparib Maintenance Therapy in Platinum-Sensitive, Recurrent Ovarian Cancer N Engl J Med 2016; 375:2154-2164
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