sNDA Submitted for Rucaparib as Maintenace Treatment for Patients With Platinum-Sensitive Recurrent Ovarian Cancer

On October 9, Clovis Oncology announced that the company submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration for rucaparib (Rubraca) 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 III 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 4 months after we reported topline results … brings [us] 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 III 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 subgroups in a step-down manner: (1) BRCA-mutant; (2) homologous recombination deficiency–positive; and finally, (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. The comprehensive dataset from the trial was presented by Ledermann et al at the 2017 European Society for Medical Oncology (ESMO) Annual Conference in Madrid (Abstract LBA40_PR), and was subsequently published by Coleman et al in The Lancet.

Clovis intends to file a Marketing Authorization Application in Europe in early 2018 for the maintenance indication, upon receipt of a potential approval in Europe for the ovarian cancer treatment indication.

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®.




By continuing to browse this site you permit us and our partners to place identification cookies on your browser and agree to our use of cookies to identify you for marketing. Read our Privacy Policy to learn more.