publication date: Dec. 14, 2018

Drugs & Targets

European Commission adopted positive opinion of rucaparib in platinum-based chemotherapy

Clovis Oncology Inc. said the European Union’s European Medicines Agency Committee for Medicinal Products for Human Use has adopted a positive opinion recommending an additional indication to include rucaparib as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy. 

EC approval is anticipated in the first quarter of 2019, the company said.

Rubraca’s indication will expand beyond its initial marketing authorization in Europe granted in May 2018 for adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum-based chemotherapy, and who are unable to tolerate further platinum-based chemotherapy.

The CHMP’s positive opinion for this additional indication was based on data from the phase III ARIEL3 clinical trial, which found that rucaparib significantly improved progression-free survival in all ovarian cancer patient populations studied.

“The CHMP recommendation represents an important step forward for women with recurrent ovarian cancer, for whom additional treatment options are needed,” said Jonathan Ledermann, Professor of Medical Oncology, UCL Cancer Institute and UCL Hospitals, London, global principal investigator for non-US sites in the ARIEL3 study. “The ARIEL3 trial demonstrated rucaparib to be effective across all patient types, regardless of their BRCA mutation status, and is the only PARP-inhibitor trial in which independent radiological review reported a median progression-free survival  of more than one year across the entire population studied. The meaningful efficacy data and tolerable safety profile offers women diagnosed … Continue reading European Commission adopted positive opinion of rucaparib in platinum-based chemotherapy

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