Monday February 3, 2020 0 comments
BOULDER -- Clovis Oncology, Inc. (NASDAQ: CLVS) today announced that Rubraca® (rucaparib) is now available and reimbursed in France.
Rubraca is 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.
“This is excellent news as this represents an important new option for patients with relapsed ovarian cancer who have responded to platinum-based chemotherapy,” said a spokesperson for IMAGYN, the only French network of patient associations involved in the fight against ovarian cancer and gynecological tumors.
“For too long, ovarian cancer treatment options beyond chemotherapy, surgery and anti-angiogenic therapy have been limited, and today’s announcement means that eligible women with ovarian cancer have more choice in their treatment than ever before.”
Approximately 5,000 women are diagnosed with ovarian cancer in France every year, which equates to roughly 14 every day. Ovarian cancer is the eighth most common cancer in women and the fourth most fatal cancer in France.
In addition, approximately 25 percent of ovarian cancer patients harbor a BRCA1/2 mutation in the tumor, correlating to improved outcomes to platinum and PARP inhibitors therapy. The majority of women diagnosed with ovarian cancer are BRCA wild-type, and 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.7
“The availability of rucaparib is good news, as ovarian cancer is a disease often diagnosed at an advanced stage and many women may have a poor prognosis,” said Professor Isabelle Ray-Coquard, president of the GINECO Group, which specializes in clinical and translational research in the field of women's cancers, and sets up and coordinates clinical trials in France and abroad.
“Patients with relapsed ovarian cancer may have many debilitating symptoms, and it is important that new treatments such as rucaparib are made available to the eligible patients that may benefit from them.”
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 this population, the risk of progression or death has been decreased by 64%. 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 fact that rucaparib is now reimbursed and available in France means there is a new treatment for patients with platinum-sensitive relapsed ovarian cancer,” said Dr. Anne Floquet, president of the SFOG, the French Society for Gyneco-Oncology.
“I am very proud to have been able to participate in the ARIEL3 study, which demonstrates the effectiveness of rucaparib in improving patients' progression-free survival. I am also delighted to be able to prescribe this treatment as it may offer benefits for eligible patients."
“We are working to make Rubraca available in multiple countries across Europe, and with the reimbursement and availability of Rubraca in France, it is now a treatment option for eligible patients in Germany, England, Italy, and in France,” said Patrick J. Mahaffy, Clovis president and CEO.
“Rubraca is effective across a broad population of women with relapsed ovarian cancer and is an important step in the ovarian cancer treatment pathway for eligible patients.”