Akynzeo netupitant/palonosetron regulatory update

EMA’s CHMP recommended approval of Akynzeo netupitant/palonosetron (NEPA) from Helsinn to prevent acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based cancer chemotherapy or with moderately emetogenic cancer chemotherapy. The product is a fixed-dose combination of 300 mg netupitant, a neurokinin 1 (NK1) substance P receptor antagonist, and 0.5 mg palonosetron, a selective serotonin (5-HT3) receptor antagonist. FDA approved Akynzeo last year for chemotherapy-induced nausea and vomiting (CINV) (see BioCentury, Oct. 13, 2014). ...