FDA approves Helsinn's palonosetron

The US FDA has granted marketing approval to Helsinn Healthcare's palonosetron for the prevention of acute nausea and vomiting associated with initial and repeat courses of moderately and highly emetogenic cancer chemotherapy; and the prevention of delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.

Palonosetron is a selective 5-HT3 receptor antagonist with a strong receptor-binding affinity and an extended plasma half-life of approximately 40 hours. Altogether, some 2,800 patients or subjects have participated in its clinical trials.

'The new indications for palonosetron advance the standards of therapy for delayed emesis due to moderately emetogenic chemotherapy,' said Dr Steven M. Grunberg, lead consultant on the palonosetron pivotal programme and professor of Medicine and Pharmacology, Fletcher Allen Healthcare, University of Vermont. 'Palonosetron is the first 5-HT3 receptor antagonist to be granted approval for prevention of delayed emesis with a single dose in this patient population.'

Helsinn acquired the worldwide rights to palonosetron from Syntex in 1998 while the drug was in phase 2 development and established a complete development programme in the US and in Europe involving over 1800 patients. The palonosetron NDA was submitted in September 2002. Helsinn granted the US and Canadian distribution and licensing rights to MGI Pharma in April 2001.

The drug will be commercialised under its new trademark Aloxi in the US by Helsinn's licensee MGI Pharma, an oncology focused biopharmaceutical company.

The worldwide market for 5-HT3 antagonists is more than US$2bn (Euro 1.75bn). The most important single market is the US where the sales were estimated to total $1.4bn (Euro 1.2bn) in 2002. The European market is approximately $350m (Euro 307m) million while the Japanese market is estimated to be $200m (Euro 175m).