This article is more than 5 years old. Information may no longer be current.
FDA approves Sustol to prevent chemotherapy-induced nausea and vomiting
Click Here to Manage Email Alerts
The FDA approved granisetron for use in combination with other antiemetics to prevent acute or delayed chemotherapy-induced nausea and vomiting in adults.
Granisetron (Sustol, Heron Therapeutics) is the first extended-release serotonin-3 (5-HT3) receptor antagonist approved for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) for patients who undergo moderately emetogenic chemotherapy, or anthracycline and cyclophosphamide combination chemotherapy. The latter regimen is a standard regimen for patients with breast cancer and other malignancies.
The FDA based the approval on results of a phase 3 development program comprised of two large, guideline-based clinical trials that evaluated the safety and efficacy of granisetron in more than 2,000 patients with cancer in both the acute phase — day 1 following chemotherapy — and the delayed phase, or days 2 through 5 after chemotherapy.
“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,” Ralph V. Boccia, MD, FACP, medical director at the Center for Cancer and Blood Disorders in Maryland, said in a Heron Therapeutics-issued press release. “In our experience, other 5-HT3 receptor antagonists ... are generally effective for 48 hours or less. Granisetron, due to its extended-release profile, represents a novel option that can protect patients from chemotherapy-induced nausea and vomiting for a full 5 days.”
The most common adverse reactions in granisetron-treated patients include injection site reactions, fatigue, headache, diarrhea, abdominal pain, insomnia, dyspepsia, dizziness, asthenia and gastroesophageal reflux.
The U.S. commercial launch is planned for the fourth quarter of this year.
“The approval of granisetron is a major step in Heron’s evolution into a fully integrated biopharmaceutical company with both development and commercial capabilities,” Robert H. Rosen, president of Heron Therapeutics, said in the press release. “Our focus now turns to ensuring patients have access to this important therapy. We look forward to collaborating with the oncology community to make granisetron available in the fourth quarter of this year.”