Dr. Cosgrove on the Approval of Niraparib in Advanced Ovarian Cancer

Casey M. Cosgrove, MD
Published: Friday, Jan 24, 2020



Casey M. Cosgrove, MD, gynecologic oncologist, The Ohio State University Comprehensive Cancer Center–James, and assistant professor, Department of Gynecologic Oncology, The Ohio State University College of Medicine, discusses the approval of niraparib (Zejula) in advanced ovarian cancer.

In October 2019, niraparib was granted FDA approval for the treatment of patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with ≥3 prior chemotherapy regimens, and whose cancer is associated with homologous recombination deficiency (HRD)–positive status.

The approval was based on the single-arm, phase II QUADRA trial which showed an overall response rate (ORR) of 24% with niraparib monotherapy (95% CI, 16-34). Moreover, patients with platinum-sensitive, BRCA-mutant ovarian cancer had an ORR of 39% (95% CI, 17-64) compared with 29% (95% CI, 11-52) and 19% (95% CI, 4-46) in those with platinum-resistant disease and platinum-refractory disease, respectively.

HRD has been shown to be a predictive biomarker for response to PARP inhibitors in this space, concludes Cosgrove.
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Casey M. Cosgrove, MD, gynecologic oncologist, The Ohio State University Comprehensive Cancer Center–James, and assistant professor, Department of Gynecologic Oncology, The Ohio State University College of Medicine, discusses the approval of niraparib (Zejula) in advanced ovarian cancer.

In October 2019, niraparib was granted FDA approval for the treatment of patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with ≥3 prior chemotherapy regimens, and whose cancer is associated with homologous recombination deficiency (HRD)–positive status.

The approval was based on the single-arm, phase II QUADRA trial which showed an overall response rate (ORR) of 24% with niraparib monotherapy (95% CI, 16-34). Moreover, patients with platinum-sensitive, BRCA-mutant ovarian cancer had an ORR of 39% (95% CI, 17-64) compared with 29% (95% CI, 11-52) and 19% (95% CI, 4-46) in those with platinum-resistant disease and platinum-refractory disease, respectively.

HRD has been shown to be a predictive biomarker for response to PARP inhibitors in this space, concludes Cosgrove.



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