Palonosetron Indicated for CINV Prevention in Pediatric Patients

August 2014 Vol 7, Special Issue ASCO 2014 Payers' Perspectives in Oncology - FDA Approvals

On May 28, 2014, the FDA approved a new indication for palonosetron HCl (Aloxi; Eisai) injection for the prevention of acute chemotherapy-induced nausea and vomiting (CINV) associated with initial or repeated courses of emetogenic chemotherapy in children aged 1 month to <17 years. This is the first FDA approval of a therapy for the prevention of acute CINV in patients aged 1 month to 6 months.

The FDA approval was based on 1 randomized, double-blind, noninferiority pivotal trial comparing palonosetron with ondansetron in pediatric patients. The primary end point was complete response (CR), defined as no vomiting, retching, or antiemesis rescue medication required within the first 24 hours after chemotherapy. CR was achieved in 59.4% of the patients using palonosetron compared with 58.6% of patients receiving ondansetron.

The trial also showed that pediatric patients required a higher dose of palonosetron based on weight than that required by adults. The most frequently reported adverse event with palonosetron was headache.

Palonosetron HCl is already approved for the prevention of CINV in adults aged ≥17 years.

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