Clovis Oncology seeks to expand its approval for Rubraca (rucaparib) to include maintenance therapy for women with recurrent ovarian cancer who respond to platinum-based chemotherapy.
The company, based in Boulder, Colorado, has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) and plans to seek similar approval from the European Medicines Agency (EMA) in early 2018.
“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,” Patrick J. Mahaffy, president and CEO of Clovis, said in a press release.
The company’s FDA application builds on data from the Phase 3 ARIEL3 trial (NCT01968213), which included 564 women with high-grade ovarian, fallopian tube or primary peritoneal cancer who had at least a partial response to platinum chemotherapy.
The data — first revealed in June and then presented in its entirety at last month’s European Society for Medical Oncology (ESMO) 2017 Congress in Madrid — showed that Rubraca held disease at bay for longer than a placebo, and researchers said that it was even seen to boost the response to earlier chemotherapy.
The trial included patients with different molecular types of cancer — those with BRCA mutations and another group with insufficient DNA repair with high loss of heterozygosity — a term that implies that one of two gene copies are lost.
The groups did not benefit equally, but the progression-free survival in the entire study was 13.7 months. Women with BRCA mutations had a progression-free survival of 26.8 months. Researchers have since published the results in the journal The Lancet.
“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,” said Mahaffy.
Rubraca is not approved in Europe, where the EMA is still reviewing the original marketing application for Rubraca as an ovarian cancer treatment in women with BRCA mutations. Clovis says it will await the EMA’s decision on its original application before submitting an application covering the use of Rubraca as a maintenance treatment.