European Commission Approves Clovis’ Rubraca for Recurrent Ovarian Cancer

European Commission Approves Clovis’ Rubraca for Recurrent Ovarian Cancer

The European Commission recently authorized Rubraca (rucaparib) for the treatment for women with recurrent BRCA-mutant ovarian cancer with relapsed or progressive disease.

The recent approval is for the maintenance treatment of recurrent epithelial, ovarian, fallopian tube or primary peritoneal cancer in women who are in a complete or partial response to platinum-based 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’s active compound, rucaparib, was discovered by a collaborative team of researchers known as the Newcastle Cancer Drug Discovery Group. Today, Rubraca is developed by Clovis Oncology.

Rubraca was first approved by the U.S. Food and Drug Administration in December 2016 for the treatment of adults with deleterious germline or somatic BRCA-mutated advanced OC who have been treated with two or more prior lines of chemotherapy.

In April, the FDA approved Rubraca for the maintenance treatment of recurrent epithelial, ovarian, fallopian tube or primary peritoneal cancer in women who are in a complete or partial response to platinum-based chemotherapy.

“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.

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