In the pivotal trial conducted at 31 U.S. sites, Rituxan, when used alone, showed a 48 percent overall response rate. Eighty of 166 patients experienced tumor shrinkage of 50 percent or greater following four weekly infusions. The median duration of response is projected to be 10-12 months.
Patients continue to be monitored.
These results corroborated those seen in earlier studies. Other events which occurred with less frequency included nausea, rashes, fatigue and headache. More serious events included hypotension, wheezing, sensation of tongue or throat swelling and recurrence of cardiac events in patients with a history of angina or arrhythmia. These symptoms were usually limited in duration to the period of infusion and decreased with subsequent infusions. It is expected to be commercially available for use within approximately three weeks.