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).