Helsinn And Eisai Receive FDA Approval For CINV Drug For Children
Switzerland-based Helsinn Group and Eisai announced that the Food and Drug Administration (FDA) has approved Aloxi (palonosetron HCl) injection for the prevention of acute chemotherapy-induced nausea and vomiting (CINV) related to initial and repeat courses of emetogenic cancer chemotherapy in pediatric patients ages 1 month to 17 years old.
Chemotherapy-induced nausea and vomiting is one of the most common side effects following chemotherapy in cancer patients. CINV affects 35 to 80 percent of young patients. The condition is thought to be caused by the chemotherapy’s release of serotonin from the enterochromaffin cells of the small intestine which then activates 5-HT3 receptors located on vagal afferents and initiates the vomiting reflex.
Aloxi is a prescription drug indicated in adults to help prevent CINV at its onset and up to five days later with chemotherapy. The drug is the first to be approved for patients aged 1 to 6 months. Considering that the peak incidence of cancer in children occurs within their first year of life, this approval will make the drug a crucial treatment option for children and infants undergoing chemotherapy.
Yuji Matsue, chairman and CEO of Eisai, said, “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. Cancer treatment is trying as it is. Our hope is that an additional option may help make cancer treatment less nauseating for some patients.”
Riccardo Braglia, CEO of Helsinn Group, said, “The prevention of nausea and vomiting induced by chemotherapy remains an unmet need in children, despite available therapies. This approval provides access to a new treatment option for CINV prevention.”
The FDA approval was supported by positive results from a double-blind, randomized, non-inferiority, pivotal trial assessing single-dose intravenous (IV) Aloxi against IV ondansetron regimen. The single-dose drug achieved its primary endpoint and did not cause vomiting, retching, and patients did not require antiemesis rescue medication.