BOULDER, Colo.–(BUSINESS WIRE)–Clovis Oncology (NASDAQ: CLVS) announced today that the company has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for rucaparib as maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. The sNDA submission is based on data from the phase 3 ARIEL3 clinical trial, which found that rucaparib significantly improved progression-free survival in all ovarian cancer patient populations studied.
“The submission of the sNDA for rucaparib in the ovarian cancer maintenance setting just four months after we reported topline results marks an important milestone that brings Clovis closer to our ultimate goal of making rucaparib available to a broader population of women with advanced ovarian cancer,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “We believe that the ARIEL3 results demonstrate the potential of rucaparib to provide a new, much-needed therapeutic option for women with advanced ovarian cancer.”
The phase 3 ARIEL3 clinical trial forms the basis of the rucaparib sNDA. 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 2017. The comprehensive dataset from the trial was presented at the 2017 European Society for Medical Oncology (ESMO) Annual Conference in Madrid, Spain,i and subsequently published in The Lancet.ii
Clovis intends to file a Marketing Authorization Application (MAA) in Europe in early 2018 for the maintenance indication, upon receipt of a potential approval in Europe for the ovarian cancer treatment indication.
