Dr. Birrer on FDA Approval of Rucaparib in Ovarian Cancer

Michael Birrer, MD, PhD, director of Medical Gynecologic Oncology at Massachusetts General Hospital, discusses the FDA approval of rucaparib (Rubraca) for as a treatment for patients with BRCA-positive advanced ovarian cancer who have received at least 2 prior lines of chemotherapy.

The approval is based on data from 106 patients across 2 trials, including the ARIEL2 study. In a pooled analysis of data from the studies, the objective response rate (ORR) was 54% (95% CI, 44-64) with rucaparib.

The 106 patients comprised 42 patients from a phase I/II study (NCT01482715) and 64 patients from the ARIEL2 phase II study (NCT01891344). Both trials were multicenter, single-arm, open-label studies in patients with BRCA-positive ovarian cancer who had progressed on 2 or more prior chemotherapies.

The phase I/II trial included only platinum-sensitive patients, while ARIEL2 enrolled patients who were platinum sensitive, resistant, or refractory. The group of 106 patients had a median number of prior therapies of 3 and a median age of 59 years.