The US Food and Drug Administration (FDA) has approved palonosetron HCL (Aloxi, Eisai Inc and Helsinn Group) injection for the prevention of chemotherapy-induced nausea and vomiting (CINV) in children aged from 1 month to less than 17 years, according to a company statement.
Palonosetron is approved for preventing acute nausea and vomiting caused by initial and repeat courses of emetogenic cancer chemotherapy (including highly emetogenic cancer chemotherapy).
This is the first product to be approved for acute CIVN prevention in children aged 1 to 6 months. The approval for this age group is important because peak cancer incidence among children occurs during the first year of life, according to the company.
"The prevention of nausea and vomiting induced by chemotherapy remains an unmet need in children, despite available therapies," Riccardo Braglia, chief executive officer, Helsinn Group, said in the company release. "This approval provides access to a new treatment option for CINV prevention."
CINV is one of the most frequent adverse effects in patients undergoing chemotherapy for cancer and has been reported in 35% to 80% of children with cancer.
The company conducted 4 pediatric clinical trials in response to a written request from the FDA. The approval follows a review of data from a randomized, double-blind, noninferiority pivotal trial that compared single-dose intravenous palonosetron 20 μg/kg given 30 minutes before chemotherapy with a standard of care intravenous ondansetron regimen of 0.15 mg/kg given 30 minutes before chemotherapy followed by infusions 4 and 8 hours after the first dose of ondansetron. The study's primary endpoint was complete response, which the researchers defined as no vomiting, no retching, and no antiemesis rescue required within the first 24 hours after chemotherapy. The primary endpoint was achieved in 59.4% of those who received the drug vs 58.6% of those who received the ondansetron regimen.
The occurrence of treatment-emergent adverse events (TEAEs) was comparable across both groups. The most commonly reported TEAE in the palonosetron group was headache. The study showed that pediatric patients need a higher dose based on weight than adults to prevent CINV, but the study confirmed that the safety profile is consistent with the established profile in adults.
The clinical trial data met the FDA's Written Request requirements for pediatric exclusivity, so the drug has an additional 6 months of US market exclusivity, which will expire on October 13, 2015.
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Cite this: FDA OKs Palonosetron (Aloxi) for Chemo-Induced Nausea, Vomiting in Children - Medscape - Jun 02, 2014.