FDA Approves Rucaparib for BRCA-positive Ovarian Cancer
The FDA has granted accelerated approval to rucaparib for the treatment of patients with deleterious germline and/or somatic ovarian cancer.
The U.S. Food and Drug Administration has granted accelerated approval to rucaparib for the treatment of patients with deleterious germline and/or somatic BRCA mutation-positive advanced ovarian cancer who have received 2 or more chemotherapy regimens.1
Approval of rucaparib was based on results from 2 multicenter, single arm, open-label clinical trials that evaluated the efficacy of rucaparib in 106 patients with advanced ovarian cancer who had experienced disease progression after 2 or more prior lines of chemotherapy. All patients received rucaparib 600 mg orally twice daily.
The studies demonstrated an objective response rate of 54% (95% CI, 44-64) and a median duration of response of 9.2 months (95% CI, 6.6-11.6) in responders.
Of the 79 patients sensitive to platinum therapy, 66% (95% CI, 54-76) achieved an objective response, compared with 25% (95% CI, 9-49) of the 20 patients with platinum-resistant disease. No platinum-refractory patients (95% CI, 0-41) had a response.
Response to rucaparib was similar regardless of whether patients had a BRCA1 or BRCA2 mutation.
Among the 377 patients assessed for safety of rucaparib, the most common adverse events were nausea, fatigue, vomiting, anemia, abdominal pain, dysgeusia, constipation, reduced appetite, diarrhea, thrombocytopenia, and dyspnea. Ten percent of patients discontinued therapy due adverse events.
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Clinicians should monitor patients for hematologic toxicity at baseline and monthly thereafter as rucaparib may increase the risk for developing myelodysplastic syndrome/acute myeloid leukemia.
The recommended dose and schedule for rucaparib is 600 mg orally twice daily with or without food.
- Rucaparib. U.S. Food and Drug Administration website. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm533891.htm. Published December 19, 2016. Accessed December 19, 2016.