10 April 2018 - - Boulder, Colorado anti-cancer agent specialist Clovis Oncology, Inc. (NASDAQ: CLVS) has received US Food and Drug Administration approval for Rubraca (rucaparib) tablets for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy, the company said.
FDA granted regular approval for Rubraca in this second, broader and earlier-line indication on a priority review timeline based on positive data from the phase 3 ARIEL3 clinical trial.
ARIEL3 successfully achieved both its primary and key secondary endpoints, extending investigator assessed progression-free survival versus placebo in all patients treated, regardless of BRCA status.
Biomarker testing is not required for patients to be prescribed Rubraca in this maintenance treatment indication.
In addition to granting Rubraca approval in this second indication, the FDA converted the approval of the initial treatment indication from accelerated to regular approval.
Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in ovarian cancer as well as several additional solid tumor indications. Studies open for enrollment or under consideration include ovarian, prostate, breast, gastroesophageal, pancreatic, lung and bladder cancers. Clovis holds worldwide rights for Rubraca.
Clovis Oncology, a biopharmaceutical company, focuses on acquiring, developing, and commercializing anti-cancer agents in the United States, Europe, and internationally. the company is headquartered in Boulder, Colorado, and has additional offices in San Francisco, California and Cambridge, UK.