FDA Grants Fast-Track Approval to Ovarian Cancer Drug

FDA Grants Fast-Track Approval to Ovarian Cancer Drug

MONDAY, Dec. 19, 2016 (HealthDay News) — The drug Rubraca (rucaparib) has been granted accelerated approval by the U.S. Food and Drug Administration to treat advanced ovarian cancer.

The approval is limited to cases where the cancer is caused by deleterious BRCA mutations. The FDA simultaneously approved the FoundationFocus CDxBRCA diagnostic screen. This test detects the presence of deleterious BRCA mutations in the tumors of women with ovarian cancer, the FDA said.

Rubraca was evaluated in clinical studies involving 106 women with BRCA-mutated advanced ovarian cancer. Fifty-four percent of participants given Rubraca had a complete or partial shrinkage of tumors, lasting an average of 9.2 months, the agency said.

The most common side effects of the drug included nausea, fatigue, vomiting, anemia, abdominal pain, dysgeusia, and loss of appetite. The drug was also associated with myelodysplastic syndrome, acute myeloid leukemia, and harm to a developing fetus, the FDA warned.

Rubraca is marketed by Boulder, Colo.-based Clovis Oncology.

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