Sancuso Approved for Prevention of Chemotherapy-Induced Nausea and Vomiting

Laurie Barclay, MD

September 15, 2008

September 15, 2008 — The US Food and Drug Administration (FDA) has approved the world's first licensed transdermal 5-hydroxytryptamine-3 (5HT3) receptor antagonist patch (Sancuso, ProStrakan Group) for the prevention of chemotherapy-induced nausea and vomiting (CINV).

"We've made significant progress in our understanding of chemotherapy and how to prevent its side effects, yet undergoing chemotherapy remains a challenging experience on many levels," Barbara Rogers, CRNP, MN, AOCN, an adult hematology-oncology nurse practitioner from Fox Chase Cancer Center, Philadelphia, Pennsylvania, said in a news release. "We should have zero tolerance for CINV. A patch that can be applied before treatment, releasing medication consistently into the bloodstream over a number of days, has the potential to impact patient comfort and quality of life."

The new patch contains the antiemetic medication granisetron, which is slowly and continuously released through a thin layer of adhesive, ensuring steady-state bloodstream levels for up to 5 consecutive days.

The patch, which is applied to the upper outer arm, is a useful formulation for patients with dysphagia or with poor tolerance for oral medications. The FDA has approved Sancuso for the indication of preventing nausea and vomiting for up to 5 consecutive days in patients undergoing treatment with moderately and/or highly nausea-inducing chemotherapy.

Approval was based on the findings of a multicenter, phase 3, randomized, double-blind, double-dummy, controlled study in which the efficacy, tolerability, and safety of Sancuso were compared with those of once-daily oral granisetron (2 mg). Among 641 participants who received moderately or highly nausea-inducing multiday chemotherapy, Sancuso met the primary endpoint of efficacy comparable to that of oral granisetron in achieving complete control of CINV. This endpoint was defined as the absence of vomiting and/or retching, nausea mild or absent, and no use of rescue medication from first administration of Sancuso until 24 hours after the last day of chemotherapy.

In clinical trials, the patch was generally well tolerated, with drug-related adverse reactions occurring in 8.7% of patients receiving Sancuso. Constipation was the most frequently reported drug-related adverse reaction; application site reactions were mild and did not result in discontinuation, and the incidence of skin reactions was similar to that reported with placebo. No clinically relevant drug interactions have been reported.

CINV is highly prevalent, affecting one half to more than two thirds of patients receiving chemotherapy. In addition to reduction in quality of life, CINV can have serious sequelae including dehydration, malnutrition, and electrolyte imbalance that may necessitate interruption or discontinuation of needed chemotherapy. The 5-day duration of action and patch formulation allows the use of Sancuso in patients receiving chemotherapy at home, as well as in those who are hospitalized.

The manufacturer has developed a patient assistance program to ensure the availability of Sancuso to qualified patients.

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