EU’s CHMP Supports Rubraca’s Approval for Advanced, Recurrent Ovarian Cancer

EU’s CHMP Supports Rubraca’s Approval for Advanced, Recurrent Ovarian Cancer
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 a
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