Rucaparib receives EC approval for advanced ovarian cancer
The European Commission (EC) has approved rucaparib (Rubraca) as first-line maintenance therapy for patients with advanced ovarian cancer, regardless of BRCA mutation status, who have responded following the completion of frontline platinum-based chemotherapy
The regulatory decision was backed by findings from the ATHENA-MONO portion of the international, double-blind, phase III ATHENA trial (NCT03522246), in which rucaparib elicited a median progression-free survival (PFS) of 20.2 months (95% CI, 15.2-24.7) vs 9.2 months (95% CI, 8.3-12.2) with placebo (HR, 0.52; 95% CI, 0.40-0.68; log-rank P < .0001). The PFS benefit with rucaparib was observed across all analyzed subgroups, including in patients with BRCA mutations (HR, 0.40; 95% CI, 0.21-0.75), BRCA wild-type/genetic loss heterozygosity (LOH)–high disease (HR, 0.58; 95% CI, 0.33-1.01), BRCA wild-type/LOH-low disease (HR, 0.65; 95% CI, 0.45-0.95), and BRCA wild-type/LOH-intermediate disease (HR, 0.39; 95% CI, 0.20-0.78). These findings were presented during the 2022 ASCO Annual Meeting and simultaneously published in the Journal of Clinical Oncology in June 2022.
See-
"A Randomized, Phase III Trial to Evaluate Rucaparib Monotherapy as Maintenance Treatment in Patients With Newly Diagnosed Ovarian Cancer (ATHENA–MONO/GOG-3020/ENGOT-ov45)"- Bradley J. Monk , MD; Christine Parkinson, MD; Myong Cheol Lim , MD, PhD; David M. O'Malley , MD; Ana Oaknin , MD, PhD; Michelle K. Wilson, MD; DOI: 10.1200/JCO.22.01003 Journal of Clinical Oncology 40, no. 34 (December 01, 2022) 3952-3964., Published online June 06, 2022.
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