European regulators have agreed to review Clovis’ application to expand the use of its PARP inhibitor Rubraca in the region.
The company is seeking permission to market Rubraca (rucaparib) for 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 application contains data from the Phase III ARIEL3 study, which assessed the drug in the ovarian cancer maintenance treatment setting among three populations, and showed that it significantly extended progression-free survival (PFS) versus placebo, 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.
Rubraca 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 approved in Europe in May for adults with platinum sensitive, relapsed or progressive, BRCA mutated, high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum based chemotherapy, and who are unable to tolerate further platinum based chemotherapy.