Rubraca (rucaparib) is a step closer to availability in Europe for ovarian cancer patients with relapsed or progressive disease. The E.U.’s Committee for Medicinal Products for Human Use (CHMP) recently supported the approval of the treatment.
CHMP’s positive opinion recommends conditional marketing authorization for Rubraca in patients with advanced BRCA-mutated high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancers.
To receive the treatment, patients must have received at least two prior lines of platinum-based chemotherapy and not be able to tolerate additional chemotherapy.
If the European Commission approves Rubraca for this indication, continued approval will be based on additional clinical data that demonstrates its beneficial effects in ovarian cancer patients.
A final decision by the EC is expected by mid-2018. Meanwhile, Clovis is starting an early access program for Rubraca in Europe for the same treatment indication. Access must be requested by the patient’s physician, and will only be granted to those with no currently available treatment.
For additional information on the program, patients may contact [email protected].
“This is great news for women living with this difficult disease who often have limited options available,” Patrick J. Mahaffy, president and CEO of Clovis Oncology, said in a press release.
“In addition, this opinion from CHMP paves the way for the review of Rubraca in the ovarian cancer maintenance indication,” he said.
Clovis Oncology‘s Rubraca has been approved in the U.S. since 2016 for BRCA-mutated advanced ovarian cancer.
CHMP’s opinion was based on two Phase 2 trials — Study 10 (NCT01482715) and ARIEL2 (NCT01891344) — showing that Rubraca improves response rates and delays disease progression in women with advanced, recurrent BRCA-positive ovarian cancer.
The treatment was also safe and well tolerated. Some of the most common side effects were fatigue, nausea, increased liver enzymes and creatinine, vomiting, anemia, decreased appetite, and diarrhea.
“We observed many women benefiting from [Rubraca by experiencing] extended progression-free survival with acceptable tolerability,” Rebecca Kristeleit, MD and PhD, clinical senior lecturer and consultant medical oncologist at University College London/University College London Hospitals U.K.
“The recommendation to approve Rubraca as monotherapy is welcome news, as once approved it will offer a new treatment option for women with advanced, recurrent ovarian cancer who have BRCA mutant platinum sensitive disease and are unsuitable for platinum-based chemotherapy,” she said.
More recently, a Phase 3 trial called ARIEL3 (NCT01968213) has shown that Rubraca is beneficial as a maintenance therapy for ovarian cancer. To date, women treated with Rubraca were alive and progression-free for 26.8 months, compared to 5.4 months for those who received a placebo.
Based on this data, Clovis Oncology plans to apply for expanded use of Rubraca as a maintenance therapy for ovarian cancer.