CHMP recommends approval of Akynzeo (netupitant-palonosetron) for CINV- Helsinn

The European Medicines Agency (EMA) has adopted a positive opinion recommending that Akynzeo (netupitant-palonosetron), from Helsinn, be granted approval for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based cancer chemotherapy and moderately emetogenic cancer chemotherapy. This is the first opinion given by the CHMP for a fixed dose combination targeting two key pathways involved in chemotherapy-induced nausea and vomiting (CINV) and will now be reviewed by the European Commission, which has the authority to approve medicines in the European Union (EU).

The opinion was based on data from Phase II and Phase III studies with Akynzeo including more than 2500 patients undergoing treatment with moderately and highly emetogenic chemotherapy regimens for a variety of tumor types. The adverse events reported with Akynzeo were consistent with the safety profile of the NK1 and 5-HT3 receptor antagonist classes of drugs.

Comment: competitor oral Aloxi was FDA approval in 2014 for Eisai/Helsinn to treat chemo-induced nausea and vomiting in children, thus extending its patent life to October 2015. Merck's Emend was better than placebo in chemotherapy-induced nausea and vomiting in children, in a late-stage trial. Emend is already approved for treating chemo-related nausea and vomiting in adults and had global sales of $507 million in 2013. Emend is available in oral and IV formulations but not in a fixed dose combination. Finally rolapitant from Tesaro is likely to be approved in the US in 2015.