FDA approves injectable anti-emetic granisetron for chemotherapy patients

Patient having chemotherapy

The US Food and Drug Administration (FDA) has approved granisetron for the prevention of nausea and vomiting caused by chemotherapy. 

The injectable therapy, which is marketed as Sustol by Huron Therapeutics, is an antagonist to the 5-HT3 receptor.

Huron Therapeutics says Sustol is effective for five or more days thanks to a polymer-based extended-release formulation, meaning it could prevent both delayed and acute chemotherapy-induced nausea and vomiting. 

The FDA approval has been granted following Huron’s third request – it first submitted an application for approval in 2009.

Huron’s latest submission for approval included results from a phase III trial, in which Sustol was compared as part of a three-drug regimen (including fosaprepitant and dexamethasone) with an ondansetron-based three-drug regimen in patients receiving highly emetogenic chemotherapy. Results showed that patients assigned to Sustol were significantly more likely to avoid emesis or the need for rescue medication during the delayed onset period (24–120 hours) than those assigned to ondansetron (64.7 versus 56.6%). 

The drug is approved in combination with other antiemetics for initial and repeat courses of moderately emetogenic chemotherapy or anthracycline and cyclophosphamide combination chemotherapy regimens. However, platinum-based regimes are excluded from the labelling.

Last updated
Citation
The Pharmaceutical Journal, August 2016;Online:DOI:10.1211/PJ.2016.20201568