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FDA Approves Rubraca for Advanced Ovarian Cancer

FDA news release; 2016 Dec 19

The FDA has granted accelerated approval to Rubraca (rucaparib) to treat women with a certain type of ovarian cancer. Marketed by Clovis Oncology, Inc. (Boulder, CO), Rubraca is approved for women with advanced ovarian cancer.

Indications: Rubraca is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated as monotherapy for the treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer who have been treated with 2 or more chemotherapies. Select patients for therapy based on an FDA-approved companion diagnostic for Rubraca.

Dosage and administration: The recommended dose for Rubraca is 600 mg orally twice daily with or without food. Continue treatment until disease progression or unacceptable toxicity. For adverse reactions, consider interruption of treatment or dose reduction.

Adverse reactions: The most common adverse reactions (≥20%) were nausea, fatigue (including asthenia), vomiting, anemia, abdominal pain, dysgeusia, constipation, decreased appetite, diarrhea, thrombocytopenia, and dyspnea.

Citation:

US Food and Drug Administration. FDA approves accelerated approval to new treatment for advanced ovarian cancer. FDA Web site. December 19, 2016. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm533873.htm?.... Accessed December 20, 2016.