The FDA approved Sustol (granisetron) extended-release injection. It is a serotonin-3 (5-HT3) receptor antagonist indicated in combination with other antiemetics 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.
Sustol utilizes 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 (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," commented Ralph V. Boccia, MD, FACP, Medical Director, Center for Cancer and Blood Disorders in Maryland. "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."
The Sustol global phase III development program was comprised of two, large, guideline-based clinical trials that evaluated treatment's efficacy and safety in more than 2,000 patients with cancer. The 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).