FDA Approves Extended-Release Granisetron (Sustol) for the Prevention of Chemotherapy-Induced Nausea and Vomiting

Launch planned for fourth quarter of 2016

The FDA has approved granisetron extended-release injection (Sustol, Heron Therapeutics) in combination with other antiemetics for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide combination chemotherapy regimens in adults.

Sustol, an injectable formulation of granisetron, uses a polymer-based drug delivery technology to maintain therapeutic levels of granisetron for at least five days, covering both the acute and delayed phases of chemotherapy-induced nausea and vomiting.

The Sustol global phase 3 development program consisted of two large, guideline-based clinical trials that evaluated the product’s efficacy and safety in more than 2,000 cancer patients. The efficacy of Sustol in preventing nausea and vomiting was evaluated in both the acute phase (one day after chemotherapy) and the delayed phase (two to five days after chemotherapy).

While chemotherapy is one of the most effective and commonly used treatments to help patients fight cancer, it is accompanied by debilitating adverse effects, including varying degrees of nausea and vomiting, often attributed as a leading cause of premature discontinuation of cancer treatment. Delayed nausea and vomiting is considered particularly debilitating for patients. The National Comprehensive Cancer Network and the American Society of Clinical Oncology have categorized chemotherapy regimens based on the degree to which they cause nausea and vomiting: low emetogenic chemotherapy, MEC, and highly emetogenic chemotherapy.

The U.S. commercial launch of Sustol is planned for the fourth quarter of 2016.

Source: Heron Therapeutics; August 10, 2016.