The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for Zejula (niraparib; Tesaro, Inc.) for the treatment of patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with ≥3 prior chemotherapy regimens, and who have either a BRCA mutation or homologous recombination deficiency (HRD) and have progressed >6 months after the last platinum-based chemotherapy.
The sNDA is supported by data from the multicenter, open label, single arm, phase 2 QUADRA trial that evaluated the safety and activity of Zejula in 463 patients with relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer. Patients received Zejula 300mg once daily continuously until disease progression. The primary objective was the proportion of patients achieving an investigator-assessed confirmed overall response in patients with homologous recombination deficiency (HRD)-positive tumors (including patients with BRCA and without BRCA mutations) sensitive to their last platinum-based therapy.
Results showed that within the primary efficacy population (HRD-positive, platinum-sensitive, ≥3 regimens, N=47), 28% of patients treated with Zejula achieved an overall response (N=13; 95% CI, 15.6-42.6; one-sided P =.00053).
Regarding safety, the most common drug-related grade 3 or worse adverse events were anemia (24%) and thrombocytopenia (21%); the most common serious adverse events included thrombocytopenia (34%), small intestinal obstruction (7%), and vomiting (6%); one death due to gastric hemorrhage was considered treatment related.
Mary Lynne Hedley, PhD, President and COO of Tesaro, said, “With this study, we continue to advance our mission to provide more patients with ovarian cancer an opportunity to benefit from treatment with Zejula.”
Zejula, a poly(ADP-ribose) polymerase (PARP) inhibitor, is currently indicated for maintenance treatment in adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. It is available as 100mg strength capsules in 90-count bottles.
According to the Company, the application has an estimated action date of October 24, 2019.
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This article originally appeared on MPR