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Presented data show palonosetron is a valuable option for treating pediatric patients receiving moderately to highly emetogenic chemotherapy

Helsinn Group, presented data at the International Society of Paediatric Oncology (SIOP) congress establishing that palonosetron, at a dose 20 mug/kg, is a valuable and efficacious treatment option for chemotherapy-induced nausea and vomiting (CINV) in pediatric patients up to 17 years of age. CINV is a common and distressing side-effect of chemotherapy which, if inadequately controlled, can lead to dehydration, electrolyte imbalance and hospitalization.

The data (presented at the SIOP congress in Toronto, 22-24 October, today, October 23rd) derive from a large randomized trial and establish that the investigated higher dose palonosetron (20 mug/kg), given as a single dose, demonstrated similar efficacy to multiple daily administrations of up to 32mg/day (considered current standard of care) in the prevention of CINV in pediatric patients receiving highly emetogenic chemotherapy. The results also indicated that the 20 mug/kg dose of palonosetron does not require dose adjustment according to patient age. No safety concerns were raised by the study. Therefore, the study met its primary objective demonstrating the non-inferiority of palonosetron compared with in pediatric patients up to 17 years of age.

In May 2014, the intravenous formulation of palonosetron was approved by the FDA for the prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy in pediatric patients aged from one month up to 17 years. This was the first such approval of a product for patients under six months. The incidence of cancer in children peaks within the first year of life, so the approval increases the scope of treatment options to improve the quality of life for children undergoing cancer chemotherapy.

Helsinn’s Chief Executive Officer, Riccardo Braglia, commented: “These trial data demonstrate that palonosetron athigh single dose representsa compelling treatment option for CINV in children and small infants. CINV is a distressing and dangerous condition and particularly trying for children undergoing chemotherapy, their families and caregivers.

“Helsinn is committed to offering the highest-quality supportive care to people undergoing cancer treatment and is pleased to see that palonosetron is validated by this comprehensive study.”

Methodology

This was a Phase III, double-blind, double-dummy, randomized, parallel group stratified study of 502 patients randomized to treatment across 59 clinical centers, designed to show the non-inferiority of two dose levels of palonosetron (10 mug/kg and 20 mug/kg) compared with ondansetron (0.15 mg/kg every 4 hours/day for a maximum of 32mg/day), which is considered as standard therapy.