Clovis Oncology claimed an update to the ongoing regulatory review for the Marketing Authorization Application (MAA) for Rucaparib tablets as monotherapy for the treatment of advanced ovarian cancer patients with deleterious BRCA mutation (germline and/or somatic).
Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in ovarian cancer as well as several additional solid tumor indications. In December 2017, the U.S. Food and Drug Administration (FDA) accepted the company’s supplemental New Drug Application (sNDA) for rucaparib for a second line or later maintenance treatment indication in ovarian cancer based on the ARIEL3 data.
Patrick J. Mahaffy, President and CEO of Clovis Oncology said “This potential approval also paves the way to a rapid review and potential CHMP vote for the maintenance indication by year-end in an earlier-line and all-comers population for women with advanced ovarian cancer.”
The CHMP application for the treatment indication currently under review was submitted during the fourth quarter of 2016 and was based on objective response rate and duration of response results from two multicenter, single-arm, open-label clinical trials, Study 10 and ARIEL2, in women with advanced BRCA-mutant ovarian cancer who had progressed after two or more prior chemotherapies. Patients received rucaparib orally 600 mg twice daily as monotherapy until disease progression or unacceptable toxicity.