Sancuso is a transdermal elective 5-hydroxytryptamine3 (5-HT3) receptor antagonist with little or no affinity for other serotonin receptors. During chemotherapy that induces vomiting, mucosal enterochromaffin cells release serotonin, which stimulates 5-HT3 receptors. The 5-HT3 antagonists prevent serotonin from binding to 5-HT3 receptors, thus preventing nausea and vomiting.
Sancuso is specifically indicated for the prevention of nausea and vomiting in patients receiving moderately and/or highly emetogenic chemotherapy regimens of up to 5 consecutive days duration.
Sancuso is supplied as a patch containing 34.3 mg of granisetron; it releases 3.1 mg of granisetron per 24 hours for up to 7 days. Sancuso is designed for transdermal application. The patch should be applied to the upper outer arm a minimum of 24 hours and maximum of 48 hours prior to chemotherapy. The patch should be removed a minimum of 24 hours following chemotherapy and may be worn for up to 7 days, depending on the duration of the chemotherapy regimen.
FDA approval of Sancuso was based on the results of a phase III study. This randomized, parallel group, double-blind, double-dummy study enrolled 641subjects receiving moderately (ME) or highly emetogenic (HE) multi-day chemotherapy, across international sites. The patch was applied 24 to 48 hours before the first dose of chemotherapy, and kept in place for 7 days. Oral granisetron (2 mg) was administered daily for the duration of the chemotherapy regimen, one hour before each dose of chemotherapy. The primary endpoint was the proportion of subjetcs achieving no vomiting/retching, only mild nausea and no rescue medication from the first administration until 24 hours after the start of the last day’s administration of multi-day chemotherapy. Efficacy was established in 60.2% of subjects in the Sancuso arm and 64.8% of subjects receiving oral granisetron (difference -4.89%; 95% confidence interval -12.91% to +3.13%).
Ongoing Study Commitments
Buchanan D, Muirhead K Intractable nausea and vomiting successfully related with granisetron 5-hydroxytryptamine type 3 receptor antagonists in Palliative Medicine. Palliative Medicine 2007 Dec;21(8):725-6