FDA approves Heron's therapy for chemotherapy-induced nausea

Last Updated: 2016-08-10

By Reuters Staff

(Reuters) - Heron Therapeutics Inc said its injection drug to prevent chemotherapy-induced nausea and vomiting was approved by the U.S. Food and Drug Administration.

Chemotherapy-induced nausea and vomiting (CINV) occurs in up to 80 percent of patients, according to the National Institutes of Health.

Heron's drug Sustol (granisetron) is the first extended-release 5-HT3 receptor antagonist approved for the prevention of acute and delayed nausea and vomiting associated with both moderately emetogenic chemotherapy and anthracycline and cyclophosphamide combination chemotherapy regimens, the company said.

"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," Dr. Ralph V. Boccia, Medical Director, Center for Cancer and Blood Disorders, Bethesda, Maryland, said in a company news release.

"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," Dr. Boccia said.

The drug will be launched in the fourth-quarter.