Clovis Oncology has announced the approval of its Rubraca by the European Commission (EC), when used as monotherapy for the maintenance treatment of adults with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Patients who are in complete or partial response to platinum-based chemotherapy, regardless of BRCA status, will benefit from the approval, as Rubraca (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 approval comes after data from the Phase III ARIEL3 clinical trial found that the drug significantly improved progression-free survival in all ovarian cancer patient populations studied.
The study consisted of 564 women with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer in complete or partial response to platinum-based chemotherapy, and showed that a tumour response was reported in 18% of patients compared to the 8% on placebo.
“This EC authorisation 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 Mahaffy, president and chief executive of Clovis Oncology.
“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.”
Ovarian cancer is the sixth deadliest cancer among women in Europe, of which more than 65,000 women are diagnosed annually.