Eisai and Helsinn Group today announced the 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.”