The National Institute for Health and Care Excellence (NICE) has recommended that women with relapsed ovarian cancer in England have access to rucaparib through the Cancer Drugs Fund (CDF), Clovis Oncology has announced.
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.
The EU conditional marketing authorisation 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, population, regardless of BRCA status.
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.
“Inclusion of rucaparib in the CDF as an option for maintenance treatment for patients with recurrent ovarian cancer responding to platinum-based therapy regardless of BRCA mutation status or line of treatment in the relapsed maintenance setting represents a much-needed treatment option for women with recurrent ovarian cancer,” said Jonathan Ledermann, Professor of Medical Oncology, UCL Cancer Institute and UCL Hospitals, London, global Principal Investigator for non-US sites in the ARIEL3 study.