Sustol, First Extended-Release 5-HT3 Approved for the Prevention of CINV

Online First - FDA News & Updates

On August 10, 2016, the FDA approved granisetron extended-release (Sustol; Heron Therapeutics) injection, the first extended-release 5-hydroxytryptamine (5-HT3) receptor antagonist, in combination with other antiemetic drugs in adults, for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy or anthracycline and cyclophosphamide combination chemotherapy regimens.

This long-acting formulation of granisetron is delivered through the Biochronomer polymer-based technology that allows the drug to remain in the body at therapeutic levels for at least 5 days, during the acute and delayed phases of chemotherapy-induced nausea and vomiting (CINV).

“Despite advances in the management of CINV, up to half of patients receiving chemotherapy can still experience CINV, with delayed CINV being particularly challenging to control. In our experience, other 5-HT3 receptor antagonists, including palonosetron, are generally effective for 48 hours or less. Sustol, due to its extended-release profile, represents a novel option that can protect patients from CINV for a full 5 days,” said Ralph V. Boccia, MD, FACP, Medical Director, Center for Cancer and Blood Disorders, in a press release.

The approval was based on 2 large clinical trials that evaluated granisetron’s efficacy and safety in the acute and delayed phases of CINV in more than 2000 patients with cancer. The primary end point was the complete response rate, which was defined as no emetic episodes and no use of rescue medications. In one trial, 200 patients who received granisetron extended-release after moderately emetogenic chemotherapy, 166 (83%) patients had a complete response in the acute phase of CINV, and 137 (69%) had a complete response in the delayed phase. And of 171 patients who received granisetron extended-release after anthracycline plus cyclophosphamide, 120 (70%) patients had complete response in the acute phase of CINV, and 85 (50%) patients had a complete response in the delayed phase of CINV.

The most common (≥3%) adverse reactions are injection-site reactions, constipation, fatigue, headache, diarrhea, abdominal pain, insomnia, dyspepsia, dizziness, asthenia, and gastroesophageal reflux.

 

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Last modified: November 11, 2016