Granisetron extended release regulatory update

Heron resubmitted an NDA to FDA for Sustol granisetron extended release to prevent acute and delayed chemotherapy-induced nausea and vomiting (CINV) associated with moderately or highly emetogenic chemotherapy regimens. The company expects a 6-month review. The NDA includes data from the double-blind, U.S. Phase III MAGIC trial, which showed that 500 mg subcutaneous Sustol met the primary endpoint in 942 patients receiving highly emetogenic chemotherapy (see BioCentury, July 20). ...