An advisory committee to the U.S. Food and Drug Administration, which was slated to review Cell Therapeutics Inc.'s (CTIC) New Drug Application for Pixantrone for the treatment of relapsed and refractory non-Hodgkin's lymphoma on February 10, has postponed the meeting due to severe weather conditions in the Washington, D.C. area.
The company is seeking approval of Pixantrone for the treatment of relapsed and refractory non-Hodgkin's lymphoma.
Shares of Cell Therapeutics were hammered Monday after the FDA staff questioned the efficacy and safety of the company's investigational drug Piaxntrone.
In briefing documents posted online, the FDA noted that the primary analysis of data submitted by the company would not be significant as the pivotal trial, PIX301, had enrolled only 140 patients compared to the planned sample size of 320 patients and the study was stopped early at an unplanned time point, due to poor accrual. Since PIX301 had a Special Protocol Assessment, early stopping of the study invalidates the Special Protocol Assessment, according to the documents.
The regulatory agency in its online documents said that deaths, serious adverse events, and grade 3-4 events were all more common on the Pixantrone arm. The FDA also said that Pixantrone is cardiotoxic but no conclusions can be drawn concerning its toxicity relative to other anthracyclines/anthracenediones.
The FDA will ask its panel to determine if the efficacy data submitted by Cell Therapeutics support the accelerated approval of Pixantrone for the proposed indication and whether the risk: benefit ratio is favorable for the proposed indication.
In a statement released early Tuesday, the company said that the "FDA intends to reschedule the meeting as soon as the FDA can determine a schedule that will allow them to reconvene the advisory panel".
CTIC, which has been trading in the range of $0.05-$2.23 in the past 52-weeks, closed Monday's regular trading at $0.64, down 39.62% on a volume of 116.9 million shares. In after-hours, the stock gained 4.69% to $0.67.
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