Eisai Inc. and Helsinn Group today announced the Food and Drug Administration (FDA) approval of 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 less than 17 years. This is the first approval of a product for acute chemotherapy-induced nausea and vomiting (CINV) prevention 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 offers an important option to children, and especially infants, undergoing chemotherapy.
CINV is among the most common side effects following therapy in patients with cancer. In clinical trials, CINV has been seen in 35 - 80 percent of pediatric patients.
"We are pleased with the Agency's decision to approve ALOXI in the pediatric setting, giving children with cancer another option to help prevent acute chemotherapy-induced nausea and vomiting," said Yuji Matsue, Chairman and CEO, Eisai Inc. "Cancer treatment is trying as it is. Our hope is that an additional option may help make cancer treatment less nauseating for some patients."
"The prevention of nausea and vomiting induced by chemotherapy remains an unmet need in children, despite available therapies," said Riccardo Braglia, CEO, Helsinn Group. "This approval provides access to a new treatment option for CINV prevention."
In response to a written request from the FDA, Helsinn conducted four pediatric clinical trials with ALOXI. The approval was based on a randomized, double-blind, non-inferiority pivotal trial comparing single-dose intravenous (IV) ALOXI 20 mcg/kg given 30 minutes prior to chemotherapy to a standard of care IV ondansetron regimen of 0.15 mg/kg given 30 minutes prior to chemotherapy followed by infusions four and eight hours after the first dose of ondansetron. Within the first 24 hours after chemotherapy, Complete Response, defined as no vomiting, no retching and no antiemesis rescue medication, was achieved in 59.4 percent of patients who received ALOXI 20 mcg/kg versus 58.6 percent of those who received the ondansetron regimen. This demonstrated that single-dose ALOXI met its primary endpoint.
Treatment-emergent adverse events (TEAEs) were comparable across both arms, with the most frequently reported TEAE in the palonosetron group being headaches. While this study demonstrated that pediatric patients require a higher palonosetron dose than adults to prevent CINV, the safety profile is consistent with the established profile in adults.