BETHESDA, MD 20 Dec 2016—
FDA and Clovis Oncology on December 19 announced the approval of rucaparib oral tablets as monotherapy for advanced ovarian cancer, characterized by specific deleterious BRCA mutations, in women previously treated with two or more chemotherapy regimens.
Women whose tumors may respond to rucaparib therapy are identified using the FoundationFocus CDxBRCA sequencing test, which has been approved by FDA for selection of patients for rupcaparib treatment.
Rucaparib is available now under the brand name Rubraca, according to the company.
The labeling (PDF) for rucaparib describes the therapy as an inhibitor of poly ADP-ribose polymerases, a family of enzymes involved in DNA repair.
The recommended starting dosage of rucaparib is 600 mg taken orally twice daily with or without food. Treatment should continue until the cancer progresses or unacceptable toxicity occurs.
The labeling for rucaparib includes recommendations for dosage reductions in response to adverse events that may occur during treatment.
In clinical trials, the most common adverse events reported by women treated with rucaparib were nausea, fatigue, vomiting, anemia, abdominal pain, altered sense of taste, constipation, decreased appetite, diarrhea, thrombocytopenia, and dyspnea. Abnormal laboratory results, including blood counts and tests of liver and kidney function, affected more than a third of women treated with rucaparib.
According to the labeling, rare cases of myelodysplastic syndrome and acute myeloid leukemia were reported in patients treated with rucaparib whose previous ovarian cancer regimen included DNA-damaging agents.
The labeling states that a complete blood count should be performed before initiating rucaparib therapy and monthly thereafter. Rucaparib treatment should not be initiated until after hematologic abnormalities caused by previous chemotherapy have resolved.
Rucaparib is available as 200- and 300-mg tablets packaged 60 per bottle. The medication should be stored at controlled room temperature.
Rucaparib was approved through FDA's accelerated approval pathway on the basis of data that suggest but do not confirm that the drug provides clinical benefits to patients. Additional confirmatory clinical studies of the drug are planned or underway.