FDA Approves Granisetron Extended-release for CINV Prevention
The FDA has approved granisetron extended-release injection (Sustol) for the prevention of chemotherapy-induced nausea and vomiting.
The U.S. Food and Drug Administration (FDA) has approved granisetron extended-release injection (Sustol) for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately emetogenic chemotherapy or anthracycline and cyclophosphamide (AC) combination regimens.1
Granisetron extended-release is the first extended-release 5-HT3 receptor antagonist approved for this indication. It uses polymer-based drug delivery technology to maintain therapeutic levels of granisetron for at least 5 days, thus providing coverage during both the acute and delayed phases of CINV.
Approval was based on findings from a global phase 3 development program comprising 2 large guideline-based clinical trials that assessed the efficacy and safety of granisetron extended-release in more than 2000 patients with cancer.
"Use of moderately emetogenic chemotherapy regimens is widespread, and AC-based regimens are among the most commonly prescribed highly emetogenic chemotherapy regimens," said Jeffrey Vacirca, MD, FACP, chief executive officer and director of clinical research, North Shore Hematology Oncology Associates and vice president, Community Oncology Alliance.
"The most significant challenge for my breast cancer patients receiving AC is chemotherapy-induced nausea and vomiting," said Dr Vacirca. "Sustol represents a better option to manage this devastating side effect of therapy."
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The recommended dose and schedule of this new formulation is 10 mg administered subcutaneously at least 30 minutes prior to the start of emetogenic chemotherapy on day 1. It is indicated for use in combination with dexamethasone with or without a neurokinin-1 receptor antagonist.
- Heron Therapeutics announces U.S. FDA approval of Sustol® (granisetron) extended-release injection for the prevention of chemotherapy-induced nausea and vomiting. Heron Therapeutics website. http://phx.corporate-ir.net/phoenix.zhtml?c=115565&p=irol-newsArticle&cat=news&id=2194586. Updated August 10, 2016. Accessed August 12, 2016.