Helsinn and Eisai Receive FDA Approval For Aloxi In Pediatric Chemotherapy Sickness
By Cyndi Root
Eisai and Helsinn Group announced via press release that the Food and Drug Administration (FDA) has approved Aloxi (palonosetron HCl). The injection is for pediatric patients to use to prevent nausea and vomiting associated with chemotherapy. Children as young as one month are eligible for the treatment, which is indicated for patients up to 17 years old. Acute chemotherapy-induced nausea and vomiting (CINV) is a factor in 35 to 80 percent of pediatric cancer patients. Yuji Matsue, Chairman and CEO of Eisai, said, "Cancer treatment is trying as it is. Our hope is that an additional option may help make cancer treatment less nauseating for some patients."
Aloxi
Aloxi (palonosetron HCl) is approved for adults to prevent chemotherapy sickness, and is now available for pediatric patients. Palonosetron is a 5-HT3 receptor antagonist that is thought to block 5-HT3 on vagal afferents, stopping the vomiting reflex. Aloxi side effects can be serious and include hives, chest pain, and trouble breathing. Some patients experience constipation and headache.
The FDA based its approval in part on a trial that compared Aloxi to ondansetron, a common treatment for chemotherapy sickness. Almost 60 percent of patients receiving Aloxi had no sickness within 24 hours after chemotherapy, compared to the same percentage in those taking ondansetron, proving Aloxi’s non-inferiority and meeting the trial’s primary endpoint. Adverse events were similar in both medicines, with the most common treatment-emergent adverse event (TEAE) being headaches. Studies also showed that children require a higher dose of Aloxi than adults do, however the pediatric safety profile was similar to the adult’s safety profile.
About Helsinn and Eisai
Helsinn is a private company headquartered in Switzerland. Eisai is the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co. When Eisai Inc. acquired MGI PHARMA, Inc. in 2008, it gained marketing rights to Aloxi in the U.S. and Canada from Helsinn Healthcare S.A. In 2010, Helsinn negotiated co-marketing rights with Eisai to commercialize Aloxi in the U.S. The Detail Services Agreement allowed Helsinn to establish an oncology sales organization in 2013.
Chemotherapy-Induced Nausea and Vomiting
Chemotherapy-induced nausea and vomiting (CINV) is a common side effect for cancer patients receiving chemotherapy. Chemotherapeutic agents release serotonin from the small intestine, which activates 5-HT3 receptors, inducing nausea and vomiting in many patients.