Monday March 2, 2020 0 comments
BOULDER -- Clovis Oncology, Inc. (NASDAQ: CLVS) today announced Rubraca® (rucaparib) is now available and reimbursed in Spain following the Spanish Interministerial Commission on Prices of Medicines and Health Products approval of rucaparib for reimbursement.
Clovis said rucaparib is now available as an option for monotherapy maintenance treatment for adults with relapsed, platinum-sensitive high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer that has responded to platinum-based chemotherapy.
Rucaparib is indicated for eligible patients regardless of BRCA status, which means it can be prescribed for women who harbor a BRCA mutation or who are BRCA wild-type.
“Although surgery and treatment for ovarian cancer have greatly advanced in recent years, patients face a disease that is still unknown in many aspects,” said Charo Hierro, president of ASACO, the association for those affected by ovarian and gynecological cancer.
“The launch of new drugs like rucaparib always brings hope to eligible ovarian cancer patients.”
Approximately 3,500 women are diagnosed with ovarian cancer in Spain every year, which equates to roughly 10 women every day.
Ovarian cancer accounts for about 29 percent of all malignant tumors of the female reproductive system. In addition, approximately 25 percent of patients harbor a BRCA1/2 mutation correlating to responsiveness to therapy.
The majority of women who are diagnosed with ovarian cancer are BRCA wild-type; these patients typically have a worse prognosis. Of those treated with surgery and first line chemotherapy, approximately 70 percent of patients will relapse within the first three years.
“The approval of rucaparib as maintenance treatment is an important advance in the overall treatment of patients with epithelial ovarian cancer, fallopian tube or primary peritoneal affected by a platinum-sensitive relapse,” said Dr. Ana Oaknin, head of the Gynecological Cancer Program, Vall d´Hebron Institute of Oncology (VHIO), Vall d’Hebron University Hospital, Barcelona.
“Rucaparib constitutes an important treatment option for our patients in the context of their disease, as most cases of ovarian cancer are associated with multiple relapses. For eligible patients, rucaparib may help to delay disease progression with a manageable tolerability profile.”
The European Union (EU) authorization is based on data from the pivotal phase 3 ARIEL3 clinical trial, which found that rucaparib significantly improved PFS in all ovarian cancer patient populations studied.
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 (ITT), 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.
“The reimbursement of Rubraca in Spain is an important step in the ovarian cancer treatment pathway, as it has shown to be effective across a broad population of women with relapsed ovarian cancer,” said Patrick J. Mahaffy, Clovis president and CEO.
“We are working to make Rubraca available to as many eligible patients as possible and are very pleased that it is now a treatment option in multiple European countries.”