Clinical Results
FDA Approval
The FDA approval of Sustol was based on a randomized, multicenter, double-blind, parallel group study. A single 10 mg subcutaneous dose of Sustol was compared to a single 0.25 mg intravenous dose of palonosetron hydrochloride in cancer patients administered moderately emetogenic (MEC) or anthracycline plus cyclophosphamide (AC) combination chemotherapy. Sustol or palonosetron hydrochloride was administered 30 minutes prior to chemotherapy on Day 1. Patients also received either 8 or 20 mg intravenous dexamethasone on Day 1 depending on chemotherapy regimen. Patients who received 20 mg of intravenous dexamethasone also received oral dexamethasone 8 mg twice daily on Days 2, 3, and 4. The primary endpoints were proportion of patients with complete response (CR) [defined as no emetic episodes (vomiting or retching) and no use of rescue medication] during the acute phase (0 to 24 hours) and the delayed phase (>24 to 120 hours) following the administration of chemotherapy in Cycle 1. The study design allowed for assessment of non-inferiority of Sustol to palonosetron hydrochloride in the acute and delayed phase of MEC and of AC combination chemotherapy. Non-inferiority of Sustol to palonosetron hydrochloride was demonstrated in the acute and delayed phases of MEC and of AC combination chemotherapy.