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FDA grants priority review to rucaparib for certain gynecologic cancers
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The FDA granted priority review to rucaparib for maintenance treatment of women with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer.
The designation applies to use of rucaparib (Rubraca, Clovis) — an oral, small molecule PARP inhibitor — for women who are platinum sensitive and are in complete or partial response to platinum chemotherapy, regardless of their BRCA mutation status.
The FDA based the priority review designation on results of the phase 3 ARIEL3 trial, which included 564 women with recurrent platinum-sensitive, high-grade ovarian, fallopian tube or primary peritoneal cancer.
All women received at least two prior platinum-based treatment regimens and achieved a complete or partial response.
The analysis included three prospectively defined molecular subgroups in a step-down manner: patients with BRCA-mutant tumors (n = 196), those with homologous recombination deficiency (n = 354), and the intent-to-treat population (n = 564).
As HemOnc Today previously reported, the results — presented in September at European Society for Medical Oncology Congress and published in The Lancet — showed improved PFS with rucaparib compared with placebo in all subgroups.
The most common grade 3 or higher treatment-emergent adverse events among rucaparib-treated patients included anemia/decreased hemoglobin (19%), increases in alanine or aspartate aminotransferase levels (10%), neutropenia (7%), asthenia/fatigue (7%), thrombocytopenia (5%), vomiting (4%) and nausea (4%).
A higher percentage of patients in the rucaparib group than placebo group discontinued treatment due to adverse events (13.4% vs. 1.6%).
“We are pleased that we continue to make significant progress toward our goal of delivering rucaparib to a much broader population of women with advanced ovarian cancer,” Patrick J. Mahaffy, president and CEO of Clovis Oncology, said in a company-issued press release. “We are particularly encouraged by the FDA’s decision to grant priority review to the application, which may allow us to make rucaparib available to these women in a more expeditious manner.”
The FDA previously approved rucaparib as monotherapy for treatment of women with BRCA-associated advanced ovarian cancer who underwent prior treatment with two or more chemotherapies.