The European Commission approved the use of Rubraca (rucaparib) for a second indication, as monotherapy for the maintenance treatment of adults with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.
The drug is sponsored by Clovis Oncology Inc.
This expands Rubraca’s indication beyond its initial marketing authorization in Europe granted in May 2018 and with this label expansion, rucaparib is now available to patients regardless of their BRCA mutation status.
Rucaparib was the first PARP inhibitor licensed for an ovarian cancer treatment indication in the EU and is now the first to be available for both treatment and maintenance treatment among eligible patients.
The EC authorization is based on data from the phase III ARIEL3 clinical trial, which found that rucaparib significantly improved progression-free survival in all ovarian cancer patient populations studied.
The ARIEL3 trial was a double-blind, placebo-controlled clinical trial of rucaparib that enrolled 564 women with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer in complete or partial response to platinum-based chemotherapy. Patients were randomized (2:1) to receive rucaparib tablets 600mg twice daily (n=375) or placebo (n=189).
ARIEL3 successfully achieved its primary endpoint, of extending investigator-assessed progression-free survival versus placebo in all patients treated (intention-to-treat), population, regardless of BRCA status; the key secondary endpoint of extending PFS as assessed by independent radiological review was also achieved.
An exploratory analysis of patients in the ITT population with measurable disease at baseline showed a tumor response was reported in 18% (95% CI 12%–26%) of patients (n=26) on rucaparib compared to 8% (95% CI 3% – 17%) of patients (n=5) on placebo (p value = 0.0069), including 10 patients (7%) in the rucaparib group who achieved a complete remission.
