Clinical data demonstrated the efficacy of AKYNZEO® in preventing CINV
90% of AKYNZEO patients receiving cisplatin had no vomiting and no rescue medication1
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Study design: Multicenter, randomized, parallel, double-blind, controlled trial in chemotherapy-naïve patients (N=694) who received CINV prophylaxis with either a single dose of AKYNZEO capsules + oral dexamethasone 12 mg on Day 1 followed by 8 mg oral dexamethasone once daily on Days 2-4 (n=135) vs a 0.5 mg oral dose of palonosetron + oral dexamethasone 20 mg on Day 1 followed by oral dexamethasone 8 mg twice daily on Days 2-4 (n=136). All patients received cisplatin (median cisplatin dose was 75 mg/m2 for each group) alone or with other chemotherapy agents. The AKYNZEO patients primarily had a diagnosis of lung/respiratory cancer (25.9%), head and neck cancer (24.4%), or ovarian cancer (17.8%). The primary endpoint was complete response in the overall phase (0-120 hours).1,2
AKYNZEO capsules demonstrated superior efficacy to palonosetron1
AKYNZEO injection has established efficacy based on bioequivalence of fosnetupitant to netupitant, and a noninferiority study with palonosetron1,3
≥90% complete response with AKYNZEO in the acute and delayed phase1
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AKYNZEO demonstrated significant improvement for secondary endpoints† in acute and delayed phases vs palonosetron, including no emesis, no significant nausea, and complete protection (P≤0.05)2
- AC=anthracycline plus cyclophosphamide; CINV=chemotherapy-induced nausea and vomiting; IV=intravenous; VAS=visual analog scale.
*AKYNZEO injection has not been studied for the prevention of nausea and vomiting associated with AC chemotherapy.
- †Protocol-defined secondary endpoints included rates of no emesis, no significant nausea (VAS <25 mm), and complete protection (complete response + no significant nausea) during acute, delayed, and overall phases.2