The Food and Drug Administration (FDA) has approved Zejula (niraparib capsules; Tesaro) for the maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Zejula is the first poly (ADP-ribose) polymerase (PARP) inhibitor to be approved by the FDA that does not require BRCA mutation or other biomarker testing.
“Until recently, there have been few treatment advances for women with recurrent ovarian cancer and even fewer options available for women who do not harbor BRCA mutations,” said Dr. Ursula Matulonis, MD, Director, Gynecologic Oncology at Dana-Farber Cancer Institute and Professor of Medicine, Harvard Medical School.
The FDA approval was supported by data from NOVA, a randomized trial (n=533) of patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received ≥2 prior treatments of platinum-based chemotherapy and were in a complete or partial response to the most recent treatment. Patients were randomized to either niraparib 300mg daily or placebo.
Based on their BRCA analysis CDx, patients with deleterious or suspected deleterious germline BRCA mutations (gBRCAm) were assigned to the germline BRCA-mutated (gBRCAmut) cohort (n=203), and those without germline BRCA mutations were assigned to the non-gBRCAmut cohort (n=350).
The results showed a statistically significant improvement in progression-free survival (PFS) for niraparib patients vs. placebo in both cohorts. The estimated median PFS for those taking niraparib who had a germline BRCA mutation was 21 months vs. 5.5 months for those in the gBRCAmut cohort taking placebo (hazard ratio [HR] 0.26, 95% CI: 0.17, 0.41; P<0.0001). The estimated median PFS for niraparib patients without a germline BRCA mutation was 9.3 months vs. 3.9 months for those in the non-gBRCAmut cohort receiving placebo (HR 0.45, 95% CI: 0.34, 0.61, P<0.0001).
The safety analysis (n=367) found the most common adverse reactions to be thrombocytopenia, anemia, neutropenia, leukopenia, palpitations, nausea, constipation, vomiting, abdominal pain/distention, mucositis/stomatitis, diarrhea, and others.
Zejula is an inhibitor of PARP enzymes, PARP-1 and PARP-2, which play a role in DNA repair. Zejula-induced cytotoxicity may involve inhibition of PARP enzymatic activity and increased formation of PARP-DNA complexes resulting in DNA damage, apoptosis and cell death.
Zejula will be available as 100mg strength capsules in 90-count bottles.
For more information call (844) 4-TESARO or visit Tesaro.com.