BRIEF—Clovis Oncology's Rubraca not to be used as monotherapy in later line BRCAm

Clovis Oncology, in agreement with the European Medicines Agency (EMA) and the German Federal Institute for Drugs and Medical Devices, has informed that its drug Rubraca (rucaparib camsylate) should no longer be used as monotherapy treatment of 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 EMA made the recommendation following its review of final data from the ARIEL4 study, which compared Rubraca with chemotherapy in patients whose cancer had come back after at least two previous treatments and who were still eligible for further chemotherapy.

The final analysis of overall survival showed that Rubraca was not as effective as chemotherapy at prolonging patients’ lives: those treated with Rubraca lived for an average of 19.4 months, compared with 25.4 months for patients receiving chemotherapy.