SEATTLE (AP) -- Cell Therapeutics said Monday the Food and Drug Administration cleared a third-party manufacturing site for its experimental cancer drug.
The drug pixantrone is being manufactured in a facility in Nerviano, Italy that is owned by Nerviano Medical Sciences.
Pixantrone is still under review by the Food and Drug Administration as a potential treatment for aggressive non-Hodgkin's lymphoma that has not responded to other therapies, or returned after other treatments.
Shares of Cell Therapeutics slumped early last month after the FDA questioned the safety and effectiveness of the drug. The agency said pixantrone could be linked to heart failure. Also, the FDA questioned the strength of the company's study, which enrolled significantly fewer patients than originally planned.
An advisory panel of experts will review pixantrone on March 22 and make a recommendation to the FDA. Regulators are expected to make a final decision by April 23.
Shares of Cell Therapeutics Inc. jumped 22 cents, or 25 percent, to $1.12 in morning trading. The stock has traded between 5 cents and $2.23 over the last 52 weeks.
