The European Commission has extended Rubraca‘s (rucaparib) approval as a maintenance therapy for women with advanced, relapsed ovarian cancer who are in complete or partial response to platinum-based chemotherapy.
This recent approval — which makes Rubraca available to all women regardless of their BRCA mutational status — is an extension of a marketing authorization granted in May 2018 for women with BRCA-mutated ovarian cancer. It covers patients with high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer.
“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,” Patrick J. Mahaffy, president and CEO of Clovis Oncology, said in a press release.
Rubraca is a kind of treatment called a PARP inhibitor. PARP enzymes are key in repairing damage to the cell’s DNA, meaning their activity in cancer cells allows them to survive. PARP inhibitors prevent the enzymes from doing their job, leading to the accumulation of DNA damage, and ultimately triggering the death of these cancer cells.
The European Commission’s decision was based on data from the Phase 3 ARIEL3 trial (NCT01968213), where Rubraca maintenance extended the time patients lived without disease progression from 5.4 months to 10.8 months – representing a 64% reduction in the risk of disease progression or death.
The trial included 564 women with recurrent ovarian cancer who responded to prior platinum-based chemotherapy. Of these patients, 375 received Rubraca, delivered as 600 mg tablets twice daily, and 189 were assigned a placebo.
ARIEL3’s primary goal was to determine if Rubraca maintenance kept patients without disease progression for longer periods, regardless of their BRCA status. While the treatment worked better in patients with mutations in their BRCA genes — delaying disease progression from 5.4 months to 16.6 months — or in other genes involved in DNA repair — from 5.4 months to 13.6 months — Rubraca also significantly delayed disease progression in the overall population.
In addition, among patients with measurable disease at the start of the study, Rubraca reduced the tumor burden in 18% — including 7% complete responses — compared with 8% on placebo.
Adverse reactions to Rubraca were mild to moderate, with fatigue/physical weakness, vomiting, anemia, and abdominal pain being the most common. The most common serious side effects included anemia, high levels of liver enzymes, fatigue, low levels of neutrophils, low platelets counts, and nausea. The data comes from 937 patients treated with Rubraca across several trials.
“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,” Mahaffy said.