Dr. Monk on the FDA Approval of Maintenance Rucaparib in Ovarian Cancer

Bradley J. Monk, MD, FACOG, FACS
Published: Friday, Apr 06, 2018



Bradley J. Monk, MD, FACOG, FACS, professor and director of the Division of Gynecologic Oncology at Creighton University School of Medicine at St. Joseph's Hospital and Medical Center, Arizona Oncology, discusses the FDA approval of rucaparib (Rubraca) as a maintenance therapy for patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

This is the third PARP inhibitor indication in the maintenance setting, Monk explains, in addition to niraparib (Zejula) and olaparib (Lynparza). 

The decision is based on data from the phase III ARIEL3 study, which showed that the median progression-free survival (PFS) in the overall population was 10.8 months with maintenance rucaparib versus 5.4 months with placebo.

Moreover, the overall response rate with rucaparib was 18% versus 8% with placebo. For patients with germline or somatic BRCA mutations, there was a 77% reduction in the risk of progression or death with rucaparib versus placebo.
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Bradley J. Monk, MD, FACOG, FACS, professor and director of the Division of Gynecologic Oncology at Creighton University School of Medicine at St. Joseph's Hospital and Medical Center, Arizona Oncology, discusses the FDA approval of rucaparib (Rubraca) as a maintenance therapy for patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

This is the third PARP inhibitor indication in the maintenance setting, Monk explains, in addition to niraparib (Zejula) and olaparib (Lynparza). 

The decision is based on data from the phase III ARIEL3 study, which showed that the median progression-free survival (PFS) in the overall population was 10.8 months with maintenance rucaparib versus 5.4 months with placebo.

Moreover, the overall response rate with rucaparib was 18% versus 8% with placebo. For patients with germline or somatic BRCA mutations, there was a 77% reduction in the risk of progression or death with rucaparib versus placebo.

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