Clovis Oncology announced that the Food and Drug Administration (FDA) has approved Rubraca (rucaparib) as maintenance treatment for adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.
The new approval was based on data from the Phase 3 ARIEL3 clinical trial (N=564). Rubraca was evaluated as maintenance therapy among 3 patient populations: BRCA mutant (BRCAmut+), HRD positive inclusive of BRCAmut+, and all patients treated in ARIEL3.
Treatment with Rubraca resulted in longer progression-free survival (PFS) vs placebo in all patient groups treated, regardless of BRCA status. The study achieved its primary and key secondary endpoints with a median PFS of 10.8 months with Rubraca vs 5.4 months with placebo (hazard ratio [HR] 0.36, 95% CI: 0.30, 0.45; P<0.0001) among all study patients. Among patients with a tumor BRCA (deleterious germline or somatic BRCA mutation), the PFS was 16.6 months with Rubraca vs 5.4 months with placebo (HR 0.23, 95% CI: 0.16, 0.34; P<0.0001).
Regarding safety, the observed profile was consistent with that seen in previous Rubraca studies. Nausea, fatigue/asthenia, abdominal pain/distention, rash, dysgeusia, anemia, AST/ALT elevation, and constipation were among the most commonly reported adverse reactions.
Rubraca, an oral PARP inhibitor, is already approved as monotherapy in patients with deleterious BRCA-mutation (germline and/or somatic) associated advanced ovarian cancer who have been treated with ≥2 prior lines of chemotherapy. Biomarker testing is not required when Rubraca is used as maintenance treatment. It is available as 200mg and 300mg strength tablets.
For more information call (844) 779-7707 or visit Rubraca.com.