A supplemental new drug application (sNDA) for Rubraca (rucaparib), a PARP inhibitor, has been granted a priority review by the Food and Drug Administration.
A supplemental new drug application (sNDA) for Rubraca (rucaparib), a poly (ADP-ribose) polymerase (PARP) inhibitor, to be used as a maintenance treatment for patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy, has been granted a priority review by the Food and Drug Administration (FDA), according to manufacturer Clovis Oncology.
The sNDA is based on findings from the phase 3 ARIEL3 trial, in which maintenance Rubraca improved median progression-free survival (PFS) by 11.2 months compared with placebo for patients with BRCA-mutant platinum-sensitive ovarian cancer.
For patients with germline or somatic BRCA mutations, there was a 77 percent reduction in the risk of progression or death with Rubraca versus placebo. Moreover, the median PFS with Rubraca was 16.6 months compared with 5.4 months for placebo. Similar PFS benefits were observed in patients with BRCA wild-type tumors and those with homologous recombination deficiency (HRD) or low to high loss of heterozygosity (LOH).
Under the Prescription Drug User Fee Act, the FDA is scheduled to make its decision on the sNDA by April 6, 2018.
“We are pleased that we continue to make significant progress toward our goal of delivering rucaparib to a much broader population of women with advanced ovarian cancer,” Patrick J. Mahaffy, President and CEO of Clovis Oncology, said in a press release. “We are particularly encouraged by the FDA’s decision to grant priority review to the application, which may allow us to make Rubraca available to these women in a more expeditious manner.”
Rubraca was initially approved by the FDA in December 2016 as a monotherapy for patients with ovarian cancer with a deleterious BRCA mutation following prior treatment with two or more chemotherapies.