Antiemetic Drug Gains Pediatric Indication

Eisai and the Helsinn Group announced that the FDA has approved Aloxi (palonosetron HCl) injection for the prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy, in children aged 1 month to <17 years. This marks the first approved drug for acute chemotherapy-induced nausea and vomiting (CINV) prevention in patients aged 1–6 months.

Four pediatric clinical trials were conducted to assess Aloxi as requested by the FDA. The approval was based on a randomized, double-blind, non-inferiority trial comparing single-dose Aloxi 20mcg/kg IV given 30 minutes prior to chemotherapy vs. ondansetron 0.15mg/kg IV (standard of care) given 30 minutes prior to chemotherapy followed by infusions 4 and 8 hours after the first dose of ondansetron. Within the first 24 hours after chemotherapy, Complete Response (defined as no vomiting, no retching and no antiemetic rescue medication) was achieved in 59.4% of patients who received Aloxi vs. 58.6% of those who received the ondansetron regimen.

RELATED: Antiemetic Treatments

Aloxi, a selective 5-HT3 receptor antagonist, is already approved for use in adults to help prevent acute or delayed nausea and vomiting due to initial and repeat courses of certain chemotherapy.

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