Wednesday December 6, 2017 0 comments
BOULDER -- Clovis Oncology (NASDAQ: CLVS) announced the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) for rucaparib 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 said it is seeking approval for use of rucaparib for this indication regardless of a patient’s BRCA mutation status.
“We are pleased that we continue to make significant progress toward our goal of delivering rucaparib to a much broader population of women with advanced ovarian cancer,” said Patrick J. Mahaffy, Clovis president and CEO.
“We are particularly encouraged by the FDA’s decision to grant priority review to the application, which may allow us to make rucaparib available to these women in a more expeditious manner.”
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 six months from the acceptance of the NDA.
The rucaparib sNDA was submitted to the FDA in October and is based on data from the phase 3 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: 1) BRCA mutant 2) HRD-positive; and, finally, 3) the intent-to-treat population, or all patients treated in ARIEL3.
Clovis announced positive topline results from the ARIEL3 clinical trial in June. Additional data from the trial were presented at the 2017 European Society for Medical Oncology (ESMO) Annual Conference in Madrid, Spain, and subsequently published in The Lancet.
Clovis said it intends to file a variation to the Marketing Authorization Application (MAA) in Europe in early 2018 for the maintenance indication, contingent on a potential approval in Europe for the ovarian cancer treatment indication.