PHILADELPHIASmithKline Beecham announced in a press release that the FDA has approved Kytril (granisetron HCl) Tablets, its 5-HT3 receptor antagonist, for the prevention of nausea and vomiting associated with radiation, including total body irradiation (TBI) and fractionated abdominal radiation. Kytril Tablets (2 mg, once daily) are currently indicated for the prevention of nausea and vomiting associated with emetogenic cancer therapies.
The approval was based on the review of data from two US trials. In the first trial, 18 patients undergoing TBI for bone marrow transplant received Kytril 1 hour before the first daily radiation fraction. Over the entire 4-day dosing period, 22% of Kytril patients had no vomiting vs 0% of historical controls.
In the second trial, involving 260 patients receiving fractionated upper abdominal radiation, patients given Kytril had a significantly longer time to the first episode of vomiting (35 days vs 9 days for placebo, P < .001) and a significantly longer time to first episode of nausea (11 days vs 1 day, P < .001).