The approval is for adult women with high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with at least two prior lines of platinum-based chemotherapy and are not be able to tolerate additional chemotherapy.
“Rucaparib provides a unique opportunity within Europe for women with BRCA mutated ovarian cancer, for whom platinum chemotherapy isn’t an option, to receive an oral non-chemotherapy treatment,” Rebecca Kristeleit, PhD, lecturer and consultant of medical oncology at University College London, said in a press release. “In this group of patients with limited treatment options, rucaparib provides a much-needed oral targeted therapy for these women.”
Rubraca is the first PARP inhibitor licensed for the treatment of ovarian cancer in the European Union. PARP inhibitors are a group of therapies that halt the activity of enzymes called poly ADP ribose polymerase, or PARP.
PARP proteins play a key role in the life of a cell. When a strand of DNA is broken or damaged, PARPs act as a repair crew to help fix the damaged site, allowing the cell to live.
For healthy cells, this is good, but in cancer cells where DNA repair is already compromised, PARPs can allow the cells to remain alive, grow and divide. PARP inhibitors prevent PARPs from doing their “natural” job, preventing these harmful cancer cells from proliferating.
European approval was based on data from two multicenter, open-label clinical trials, the Phase 1/2 Study 10 (NCT01482715) and the Phase 2 ARIEL2 (NCT01891344) trials. Both studies tested Rubraca in women with advanced BRCA-mutant ovarian cancer who had progressed after two or more previous chemotherapies.
All patients received Rubraca orally at 600 mg twice a day.
Both trials’ primary objective was to measure the proportion of patients who achieved a partial or complete response after receiving Rubraca — a measure called the objective response rate (ORR). Rubraca showed an ORR of 54.7% in the primary efficacy population and 64.6% in the platinum-sensitive population.
Most adverse events recorded were mild to moderate. The only serious adverse reaction recorded was anemia, which occurred in less than 2% of patients
Rubraca was first approved by the U.S. Food and Drug Administration in December 2016 as a maintenance treatment for adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancers who are responding to platinum-based chemotherapy.
At the time, Rubraca was also approved for the treatment of certain patients with deleterious BRCA mutation-associated epithelial ovarian, fallopian tube, or primary peritoneal cancers.
“Ovarian cancer is one of the most difficult cancers to detect and for this reason most women who develop the disease are often diagnosed in the advanced stages, leaving them with few viable treatment options,” said Ruth Plummer, MD, PhD, a professor at the Northern Institute for Cancer Research at Newcastle University in the U.K.
The post European Commission Approves Clovis’ Rubraca for Recurrent Ovarian Cancer appeared first on Ovarian Cancer News Today.