Production & Manufacturing
Process & Production

EMA accepts Clovis’ application for expanded indication of Rubraca to treat ovarian cancer

PBR Staff Writer Published 06 July 2018

The European Medicines Agency (EMA) has accepted Clovis Oncology’s marketing application for a new indication of Rubraca (rucaparib) as maintenance treatment for women with recurrent ovarian cancer.

The regulator has accepted the application for a type II variation to the marketing authorization for Rubracato include maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to platinum based chemotherapy.

Rucaparib is an oral and small molecule inhibitor of poly ADP-ribose polymerase 1 (PARP1), PARP2 and PARP3.

Clovis Oncology CEO and president Patrick Mahaffy said: “We are very pleased to receive validation of the variation to the Rubraca marketing authorization by the EMA, which brings us a step forward in making rucaparib available to more women with recurrent ovarian cancer in Europe.”

The application was submitted based on the positive results of phase 3 ARIEL3 study, which assessed rucaparib in the ovarian cancer maintenance treatment setting among three populations, including BRCA mutant (BRCAmut+), HRD positive inclusive of BRCAmut+ and all patients treated in ARIEL3.

According to the company, the ARIEL3 study reached its primary endpoints, extending investigator assessed progression-free survival (PFS) against placebo in all patients treated, regardless of BRCA status.

The ARIEL3 trial is a confirmatory randomized and double-blind study designed to compare the effects of rucaparib against placebo to assess whether rucaparib given as a maintenance treatment to platinum-sensitive ovarian cancer patients can extend the period of time for which the disease is controlled after a complete or partial response to platinum-based chemotherapy.

In the trial, the company recruited 564 patients with high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer.

By the end of this year, the company is expecting an opinion from the Committee for Medicinal Products for Human Use (CHMP) on the latest submission.

In May this year, Clovis secured marketing authorization for rucaparib to treat 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.

Image: Micrograph of a mucinous ovarian carcinoma. Photo: courtesy of Nephron.