The safety of rucaparib was evaluated in 377 patients with advanced ovarian cancer. The most common adverse reactions (greater than or equal to 20%) experienced by patients were nausea, fatigue (including asthenia), vomiting, anemia, abdominal pain, dysgeusia, constipation, decreased appetite, diarrhea, thrombocytopenia, and dyspnea. Adverse reactions led to dose discontinuation in 10% of patients, most frequently from fatigue/asthenia (2%).
Myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) was reported in 2 of 377 (0.5%) patients with ovarian cancer. In addition, AML was reported in 2 (<1%) patients with ovarian cancer enrolled in a blinded, randomized trial evaluating rucaparib versus placebo. Patients should be monitored for hematologic toxicity at baseline and monthly thereafter, and use of rucaparib should be discontinued if MDS/AML is confirmed.
The recommended dose and schedule for rucaparib is 600 mg (two 300 mg tablets) taken orally twice daily with or without food.
FDA granted the rucaparib application breakthrough therapy designation, priority review status, and orphan drug designation. This application was approved two months before the PDUFA goal date. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics, available at: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm358301.pdf.
Full prescribing information is available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/209115s000lbl.pdf
Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by completing a form online at http://www.fda.gov/medwatch/report.htm, by faxing (1-800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).