Rucaparib is available for use within the CDF as an option for the maintenance treatment of relapsed, platinum-sensitive high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer that has responded to platinum-based chemotherapy in adults, based on the conditions outlined in the managed access agreement.
Approximately 6,400 women are diagnosed with ovarian cancer in the UK every year, which equates to roughly 17 every day.
Despite advancements in treatment and care, more than 4,000 women still die each year from ovarian cancer in the UK.
Of those treated with surgery and first line chemotherapy, approximately 70% of patients will relapse within the first three years.
The European Union conditional marketing authorization is based on data from the pivotal Phase 3 ARIEL3 clinical trial.
ARIEL3 successfully achieved its primary endpoint of extending investigator-assessed PFS versus placebo in all patients treated (intention-to-treat, or ITT), population, regardless of BRCA status (median 10.8 months vs 5.4 months).
In addition, it successfully achieved the key secondary endpoint of extending PFS by independent radiological review versus placebo in all patients treated, regardless of BRCA status (median 13.7 months vs 5.4 months).
The overall safety profile of rucaparib is based on data from 937 patients with ovarian cancer treated with rucaparib monotherapy in clinical trials.
Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 that is being developed in multiple tumor types, including ovarian and metastatic castration-resistant prostate cancer (mCRPC), as monotherapy, and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway.
Rubraca is indicated as monotherapy for the maintenance treatment of adult patients 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.
Rubraca is indicated as monotherapy treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with ≥ 2 prior lines of platinum-based chemotherapy, and who are unable to tolerate further platinum-based chemotherapy.
Efficacy of Rubraca as treatment for relapsed or progressive EOC, FTC, or PPC has not been investigated in patients who have received prior treatment with a PARP inhibitor. Therefore, use in this patient population is not recommended.
The overall safety profile of rucaparib is based on data from 937 patients in clinical trials in ovarian cancer treated with rucaparib monotherapy.
Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercialising innovative anti-cancer agents in the US, Europe and additional international markets.
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