BRIEF: FDA will review Cell Therapeutics drug March 22 [The Seattle Times] Knight Ridder/Tribune ”Business News ”
Mar. 1 — Cell Therapeutics said the Food and Drug Administration’s rescheduled meeting to review the Seattle biotech company’s crucial cancer drug has been set for March 22 .
The meeting was postponed from Feb. 10 due to the severe snowstorm that hit Washington D.C. that week.
The FDA’s Oncologic Drugs Advisory Committee will make its recommendation on whether to approve pixantrone for the treatment of relapsed/refractory aggressive non-Hodgkin’s lymphoma, and the agency itself is expected to make a final decision on approval by April 23 .
Before the postponed meeting, FDA staff raised serious questions about the safety and effectiveness of the biotech drugmaker’s experimental cancer treatment.
In documents posted online, FDA staff questioned the strength of the company’s study, saying it “enrolled significantly fewer patients than originally planned.” In addition, the staff report said pixantrone was associated with potentially fatal cardiac side effects, including heart failure.
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