FDA Approves Extended-Release Granisetron Injection for the Prevention of Chemotherapy-Induced Nausea and Vomiting

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The U.S. Food and Drug Administration (FDA) has approved an extended-release version of granisetron (Sustol) for the prevention of chemotherapy-induced nausea and vomiting, according to a news release by Heron Therapeutics, the drug’s manufacturer. Granisetron is an extended-release, injectable 5-HT3 receptor antagonist that uses a polymer-based drug delivery technology to maintain therapeutic levels of granisetron for ≥5 days, covering both the acute and delayed phases of chemotherapy-induced nausea and vomiting.

“Up to half of patients receiving chemotherapy can still experience [chemotherapy-induced nausea and vomiting], with delayed nausea and vomiting being particularly challenging to control,” said Ralph V. Boccia, MD, FACP, Medical Director, Center for Cancer and Blood Disorders. “[Granisetron], due to its extended-release profile, represents a novel option that can protect patients for a full 5 days.”

The granisetron global phase III development program was comprised of two, large guideline-based clinical trials (clinicaltrials.gov identifiers NCT02106494, NCT00343460) that evaluated granisetron’s efficacy and safety in more than 2,000 patients with cancer. Granisetron’s efficacy in preventing nausea and vomiting was evaluated in both the acute phase (day 1 following chemotherapy) and the delayed phase (days 2–5 following chemotherapy).

“Use of moderately emetogenic chemotherapy regimens is widespread,” said Jeffrey Vacirca, MD, CEO and Director of Clinical Research, North Shore Hematology Oncology Associates. “The most significant challenge for my breast cancer patients receiving anthracycline/cyclophosphamide is nausea and vomiting. [Granisetron] represents a better option to manage this devastating side effect.” ■




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