FDA plans April decision on Cell Therapeutics drug
Wednesday, December 7, 2011
SEATTLE (AP) — Drug developer Cell Therapeutics Inc. said Tuesday the Food and Drug Administration has set a goal of deciding on its application for its potential cancer treatment pixantrone by April 24.
Cell Therapeutics wants the FDA to approve the potential treatment for an aggressive form of non-Hodgkin's lymphoma, where the disease has progressed after treatment with two or more other therapies. Non-Hodgkin's lymphoma is a type of cancer that affects white blood cells.
The Seattle company had said in October it expected the FDA to complete its review by April.
The FDA declined to approve pixantrone last year because of concerns that clinical trials did not show the drug was effective. The agency had asked Cell Therapeutics to run another clinical trial of the drug. But the company said Tuesday the agency's Office of New Drugs gave it an opportunity to resubmit its application with additional information but without conducting another trial.
Cell Therapeutics said Tuesday pixantrone also is under review for approval in Europe. An opinion from the Committee for Human Medicinal Products is expected next month.