Monday January 28, 2019 0 comments
BOULDER -- Clovis Oncology, Inc. (NASDAQ: CLVS) today announced the European Commission (EC) has approved the use of Rubraca (rucaparib) for treatment of ovarian cancer.
Specifically, the drug is approved 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 endorsement expands rucaparib’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, Clovis said.
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 3 ARIEL3 clinical trial, which found that rucaparib significantly improved progression-free survival in all ovarian cancer patient populations studied.
For the full European approved prescribing information, see the Rubraca Summary of Product Characteristics on the European Medicines Agency website.
Ovarian cancer is the sixth deadliest cancer among women in Europe, where more than 65,000 women are diagnosed annually. Moreover, the 80 to 85 percent of women diagnosed in the later stages of the disease (III and IV) have particularly poor outcomes.
Ovarian cancer is challenging to treat, and most women will relapse after surgery and chemotherapy. Multiple studies, including the rucaparib ARIEL3 clinical trial, have demonstrated that maintenance treatment with a PARP inhibitor significantly extends median progression free survival (mPFS) as compared to observation (i.e., “watch and wait” or placebo).
“This EC authorization of rucaparib is an important step in ensuring that it is available to all women who may potentially benefit, regardless of their BRCA status,” said Patrick J. Mahaffy, Clovis president and CEO.
“We believe that access to maintenance treatment is extremely important for women with relapsed platinum-sensitive ovarian cancer, and we are pleased that rucaparib can now be an option for these women.
“As the only PARP inhibitor that has shown further tumor shrinkage as well as prolonged progression-free survival in this maintenance setting, we believe Rubraca represents an important step forward for women with advanced ovarian cancer.”
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.