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FDA approves Rubraca for recurrent ovarian cancer
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The FDA approved rucaparib for the maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy, according to the agent’s manufacturer.
Rucaparib (Rubraca, Clovis Oncology) is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3. The FDA granted accelerated approval in 2016 to the agent as monotherapy for women with BRCA-associated ovarian cancer who received two or more prior chemotherapies.
The FDA based this new indication on data from the phase 3 ARIEL3 trial that included 564 patients with ovarian cancer.
ARIEL 3 successfully met its primary and key secondary endpoints.
Patients assigned rucaparib had improved PFS compared with patients assigned placebo (median, 10.8 months vs. 5.4 months; HR = 0.36; 95% CI, 0.3-0.45).
As HemOnc Today previously reported, the results from the ARIEL3 trial were presented European Society for Medical Oncology Congress in September.
“Rubraca provided statistically significant improvement in PFS versus placebo to all patients, regardless of BRCA mutation status,” Robert L. Coleman, MD, professor and executive director at Cancer Network Research and the Ann Rife Cox chair in gynecology at The University of Texas MD Anderson Cancer Center, said in a company-issued press release. “Both the efficacy and safety results from the ARIEL3 study reinforce the important role of Rubraca in the treatment of recurrent ovarian cancer and expands the treatment options for patients and physicians battling this disease.”
The safety profile of rucaparib was consistent with previous studies. The most common grade 1 to grade 4 adverse events included nausea, fatigue/asthenia, abdominal pain/distention, rash, dysgeusia, anemia, aspartate aminotransferase/alanine aminotransferase elevation, constipation, vomiting, diarrhea, thrombocytopenia, nasopharyngitis/upper respiratory tract infection, stomatitis, decreased appetite and neutropenia. Most of the events were grade 1 or grade 2.
“This FDA approval provides a meaningful advancement for the treatment of women with recurrent ovarian cancer, offering them the potential to reduce their risk [for] disease progression following platinum-based chemotherapy,” Patrick J. Mahaffy, CEO and president of Clovis Oncology, said in the release. “We are grateful that the FDA expedited review of this maintenance treatment indication, so that physicians can begin offering it to appropriate patients beginning today.”
In February, the NCCN added rucaparib for this new indication to their Clinical Practice Guidelines in Oncology Ovarian Cancer.