The FDA has accepted the supplemental New Drug Application (sNDA) for rucaparib and granted priority review status to the application with a Prescription Drug User Fee Act date of April 6, 2018. In October 2017, the sNDA submission was completed 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. Approval is being sought 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 the acceptance of the NDA.
The rucaparib sNDA 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 sub-groups in a step-down manner: BRCA mutant, HRD-positive, and 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 at the 2017 European Society for Medical Oncology Annual Conference in Madrid, Spain, and subsequently published in The Lancet (2017; http://dx.doi.org/10.1016/S0140-6736(17)32440-6).