†Phase II, multicenter, randomized, parallel, double-blind, controlled trial in chemotherapy-naïve patients (N=694) of AKYNZEO Capsules + oral dexamethasone vs oral palonosetron + oral dexamethasone in patients receiving cisplatin-based therapy. Primary endpoint was complete response in the overall phase. See Efficacy tab for more information.1,2
*In highly emetogenic chemotherapy, 90% complete response in the AKYNZEO Capsules arm (n=135) vs 77% in the palonosetron arm (n=136) (P=.003). Primary endpoint: complete response in overall phase 0–120 hours (complete response was no emesis and no use of rescue medication for 5 days across both acute and delayed CINV).1 (See additional study design.)
AKYNZEO (netupitant/palonosetron) capsules is indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy.
AKYNZEO (fosnetupitant/palonosetron) for injection is indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy.
AKYNZEO for injection has not been studied for the prevention of nausea and vomiting associated with anthracycline plus cyclophosphamide chemotherapy.
AKYNZEO is a combination of palonosetron, a serotonin-3 (5-HT3) receptor antagonist, and netupitant or fosnetupitant, substance P/neurokinin-1 (NK-1) receptor antagonists: palonosetron prevents nausea and vomiting during the acute phase and netupitant/fosnetupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy.
For more information about AKYNZEO and AKYNZEO FDA-approved patient labeling, please see the full Prescribing Information.
To report SUSPECTED ADVERSE REACTIONS, contact Helsinn at 1-84HELSINN-U (1-844-357-4668) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.