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Granisetron Patch Approved for CINV

Granisetron Patch Approved for CINV

ProStrakan Group announced the US Food and Drug Administration (FDA) approval of 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.

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