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FDA Approval for Sancuso for Prevention of Chemotherapy-Induced Nausea & Vomiting

doi: 10.1097/01.COT.0000340700.76695.b0
In Brief

The FDA has approved the use of Sancuso (Granisetron Transdermal System), the first patch to provide up to five consecutive days of control of nausea and vomiting for patients receiving a moderately and/or highly nausea-inducing chemotherapy regimen. The transdermal system delivers granisetron through a thin layer of adhesive that attaches the patch to the skin, to be released slowly and continuously into the bloodstream for up to five consecutive days.

A Phase III multicenter, randomized, double-blind, double-dummy controlled study of the transdermal system in 641 patients who received moderately or highly nausea-inducing multi-day chemotherapy met its endpoint of complete control, defined as no vomiting and/or retching, no more than mild nausea, and no rescue medication from first administration of Sancuso until 24 hours after the last day of chemotherapy.

The treatment was generally well tolerated, with adverse reactions, the most common of which was constipation, occurring in 8.7% of patients.

© 2008 Lippincott Williams & Wilkins, Inc.
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