Japan-based Eisai has received approval from the US Food and Drug Administration (FDA) for antiemetic agent Aloxi (palonosetron HCI) as an additional indication for preventing acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy in children aged from one month up to 17 years.
The company said that despite peak cancer occurances among children occurring within the first year of birth, Aloxiis is the first product for chemotherapy-induced nausea and vomiting (CINV) prevention approved in patients aged between one and six months after birth.
Eisai’s US subsidiary markets the product based on having received exclusive marketing rights from Helsinn Healthcare for the US.
FDA approval was based on a randomised, double-blind, non-inferiority pivotal trial comparing Aloxi with ondansetron in pediatric patients.
The trial’s primary endpoint of complete response was defined as no vomiting, retching or antiemesis rescue medication required within the first 24 hours after chemotherapy. It was achieved in 59.4% of patients who received Aloxi (20mcg/kg, single-dose IV) versus 58.6% of patients who had the ondansetron regimen.
The company said that treatment-emergent adverse events (TEAEs) were comparable across both arms, with the most frequently reported TEAE in the Aloxi group being headaches.
While the trial showed that pediatric patients require a higher palonosetron dose based on weight than adults to prevent CINV, the safety profile for ALOXI was confirmed as being consistent with the established profile in adults.
In addition, the clinical trial data has met the FDA’s written request requirements for pediatric exclusivity, resulting in an additional six months of US market exclusivity for the drug, which will now expire on 13 October 2015.