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:
Cisplatin Streptozocin Carmustine
Mechlorethamine Cyclophosphamide
(≥1500 mg/m2)
Oxaliplatin Irinotecan Cytarabine (>1 g/m2)
Carboplatin Daunorubicin Azacitidine
Epirubicin Doxorubicin Alemtuzumab
Idarubicin Cyclophosphamide
(<1500 mg/m2)
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:

See IV Data

  • AC=anthracycline-cyclophosphamide; CINV=chemotherapy-induced nausea and vomiting; HEC=highly emetogenic chemotherapy; MEC=moderately emetogenic chemotherapy.