FDA Accepts sNDA for Rucaparib in Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
On December 5, Clovis Oncology announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for rucaparib (Rubraca) and granted Priority Review status to the application, with a Prescription Drug User Fee Act (PDUFA) date of April 6, 2018. In October, Clovis completed its sNDA submission for rucaparib as maintenance treatment in patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are platinum-sensitive and in a complete or partial response to platinum-based chemotherapy. The company is seeking approval for use of rucaparib for this indication, regardless of a patient’s BRCA mutation status.
A Priority Review designation is granted to proposed medicines that the FDA has determined have the potential, if approved, to offer a significant improvement in the safety or effectiveness of the treatment, prevention, or diagnosis of a serious condition. Priority designation shortens the review period from the standard 10 months to 6 months from acceptance of the application.
The rucaparib sNDA was submitted to the FDA in October 2017 and is based on data from the phase III ARIEL3 clinical trial. ARIEL3 is a double-blind, placebo-controlled trial of rucaparib that enrolled 564 women with platinum-sensitive high-grade ovarian, fallopian tube, or primary peritoneal cancer. The primary efficacy analysis evaluated three prospectively defined molecular subgroups in a step-down manner: (1) BRCA-mutant; (2) homologous recombination deficiency–positive; and (3) the intent-to-treat population, or all patients treated in ARIEL3.
Positive topline results from the ARIEL3 clinical trial were announced in June 2017. Additional data from the trial were presented by Ledermann et al at the 2017 European Society for Medical Oncology Annual Conference (LBA40_PR) and subsequently published by Coleman et al in The Lancet.
About ARIEL3
The ARIEL3 study of rucaparib is a confirmatory randomized, double-blind study comparing the effects of rucaparib against placebo to evaluate whether rucaparib given as a maintenance treatment to platinum-sensitive ovarian cancer patients can extend the period for which the disease is controlled after a complete or partial response to platinum-based chemotherapy. The study enrolled 564 patients with high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer.
To be eligible for the study, participants had to have received at least two prior platinum-based treatment regimens, been sensitive to the penultimate platinum regimen, and achieved a complete or partial response to their most recent platinum-based regimen. There were no genomic selection criteria for this study. Trial participants were randomized 2:1 to receive 600 mg of rucaparib twice daily or placebo.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
