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Dr. Birrer on FDA Approval of Rucaparib in Ovarian Cancer

Michael Birrer, MD, PhD
Published: Monday, Dec 19, 2016



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.
 


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.
 

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