Clovis' PARP inhibitor Rubraca has won a second US approval, as maintenance treatment for patients with recurrent ovarian cancer.
The decision allows physicians to prescribe the tablets for adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.
Rubraca (rucaparib) is an inhibitor of poly(ADP-ribose) polymerase (PARP) enzymes that block the repair of damaged DNA in cancer cells, and, as a result, causes the cancer cells to die.
The drug was first given conditional clearance in the US for the treatment of adult patients with deleterious BRCA mutation (germline and/or somatic) associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies, which has now also been converted into full approval.
The US Food and Drug Administration’s green light in the broader and earlier-line indication is based on data from the Phase III ARIEL3 clinical trial, which achieved both its primary and key secondary endpoints, extending progression-free survival (PFS) versus placebo in all patients treated, regardless of BRCA status.
Median PFS was found to be 10.8 months for the Rubraca treated group and 5.4 months for the placebo arm. In patients with a deleterious germline or somatic BRCA mutation, the figures were 16.6 months versus 5.4 months, respectively.
“The FDA approval of Rubraca in the maintenance treatment setting is an important milestone for physicians and their patients with recurrent ovarian cancer because it offers them greater flexibility to use this novel PARP inhibitor, which has demonstrated significant clinical efficacy and has been well received in practice,” said Professor Jonathan Ledermann, clinical director, UCL Cancer Institute, and European and the rest of world principal investigator for the ARIEL3 study.
“This will enable physicians to offer Rubraca to more women with platinum-sensitive, recurrent ovarian cancer.”
Also commenting on the approval, Patrick Mahaffy, chief executive and president of Clovis Oncology, said it “provides a meaningful advancement for the treatment of women with recurrent ovarian cancer, offering them the potential to reduce their risk of disease progression following platinum-based chemotherapy.
“We are grateful that the FDA expedited review of this maintenance treatment indication, so that physicians can begin offering it to appropriate patients beginning today.”