Cell Therapeutics To File for FDA Approval of Zevalin In First-Line Lymphoma
Cell Therapeutics said today that it has been informed by FDA that results from a clinical trial of patients with newly-diagnosed lymphoma will be enough to file an application for expanded usage of Zevalin. The Seattle biotech company (NASDAQ: CTIC) said it plans to apply for FDA clearance of the expanded use in the fourth quarter. Zevalin is currently approved for relapsed forms of non-Hodgkin’s lymphoma, and the new application, if approved, would allow sale for patients getting first-line treatment. Results from a 414-patient clinical trial of Zevalin in first-line patients showed it could cause complete tumor shrinkage for 76 percent of patients with a single shot.