ProStrakan Group announced the US Food and Drug Administration (FDA) approval of granisetron(Drug information on granisetron) transdermal system (Sancuso), the first and only patch to provide up to 5 consecutive days of control 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,” said Barbara Rogers, crnp, mn, aocn, Adult Hematology-Oncology Nurse Practitioner, Fox Chase Cancer Center. “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 FDA approved Sancuso for the prevention of CINV based on the results of a multicenter phase III randomized, double-blind, double-dummy controlled study comparing the efficacy, tolerability and safety of Sancuso with once-daily oral granisetron (2 mg). The trial enrolled 641 patients who received moderately or highly nausea-inducing multiday chemotherapy, and met its primary endpoint of achieving complete control of CINV, working as well as oral granisetron. Transdermal granisetron was generally well-tolerated by patients in clinical trials.