AKYNZEO® demonstrated safety and efficacy over multiple cycles of chemotherapy
Study designed with patients undergoing initial and repeat cycles of chemotherapy who received AKYNZEO capsules1
- Multinational, multicenter, randomized, double-blind, double-dummy, parallel-group study
- The primary assessment of this multicycle study was safety, measured primarily by treatment-emergent adverse events; efficacy over multiple cycles was also evaluated
- Patients were randomized (3:1 for AKYNZEO Capsules) on Day 1 (AKYNZEO, n=309; aprepitant/palonosetron, n=104) of their first chemotherapy cycle before administration of:
HEC | ||
---|---|---|
Cisplatin† | Streptozocin | Carmustine† |
Mechlorethamine | Cyclophosphamide (≥1500 mg/m2) |
Dacarbazine† |
MEC | ||
---|---|---|
Oxaliplatin† | Irinotecan† | Cytarabine (>1 g/m2) |
Carboplatin† | Daunorubicin† | Azacitidine |
Epirubicin† | Doxorubicin† | Alemtuzumab |
Idarubicin | Cyclophosphamide† (<1500 mg/m2) |
Bendamustine |
Ifosfamide | Clofarabine |
†Cycle 1 chemotherapy.1
- There was no limit to the number of consecutive cycles for each patient1
AKYNZEO safety and efficacy results in multi-cycle chemotherapy1
- Treatment-emergent adverse events of AKYNZEO were comparable to aprepitant and palonosetron
- Efficacy in the AKYNZEO arm was maintained throughout all cycles
AKYNZEO injection: efficacy was established based on bioequivalence and noninferiority studies2,3
The efficacy of AKYNZEO for injection and AKYNZEO injection for the prevention of CINV has not been established in a clinical study of patients treated with AC chemotherapy1
View clinical trial data supporting the safety and efficacy of AKYNZEO injection:
- AC=anthracycline-cyclophosphamide; CINV=chemotherapy-induced nausea and vomiting; HEC=highly emetogenic chemotherapy; MEC=moderately emetogenic chemotherapy.