Palonosetron HCl (Aloxi; Eisai) injection received a new US Food and Drug Administration (FDA) indication 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 age of peak cancer incidence among children occurs within the first year of life, so this approval provides an important option to children, and especially infants, undergoing chemotherapy.
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, which was achieved in 59.4% of 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; however, the safety profile of the drug in pediatric patients was consistent with its safety profile in adults.
Palonosetron HCl is already approved for the prevention of CINV in adults aged ≥17 years. (May 28, 2014)