The wait for the approval of Cell Therapeutics’ (CTIC) drug, Pixuvri (pixantrone) is far from over. Recently, the US Food and Drug Administration (FDA) announced that the Oncologic Drugs Advisory Committee meeting, scheduled for Feb 10, has been postponed due to bad weather conditions in the Washington region.
Cell Therapeutics is seeking FDA approval of Pixuvri for the treatment of relapsed or refractory aggressive non-Hodgkin’s Lymphoma (NHL) in patients who have not responded to other treatment options. The FDA usually follows panel recommendations to decide on the approvability of a particular drug. A final decision on Pixuvri would be taken by April 23.
The postponement of the FDA’s committee meeting is not the end of problems at Cell Therapeutics. In an analysis for the committee, the FDA reviewers have raised various issues related to the study design. The study that opened in June 2004 sought to enroll 320 patients. However, the enrollment was challenging and was stopped in March 2008 after enrolling 140 patients, less than half the original plan.
Overall, the reviewers are of the view that pixantrone was well-tolerated with manageable toxicities. The pivotal study successfully met its primary efficacy endpoint. It was observed that 20% of patients receiving pixantrone achieved a complete remission, compared to 6% who were treated with another drug. While pixantrone could be toxic to heart, conclusions could not be drawn about its risk compared to other cancer drugs called anthracyclines.
The committee has to decide regarding the effectiveness of pixantrone and if risks associated with it outweigh the benefits. At present, investor focus is primarily on the outcome of the FDA advisory panel meeting, though the date is yet to be finalized.
A favorable outcome should weigh in pixantrone’s favor during the final approval process. While pixantrone will be the only product marketed by Cell Therapeutics, on approval, the drug will face tough competition from several other players.
Additionally, we remain concerned about the company’s liquidity position. Operating expenses are likely to increase further as the company prepares for the potential launch of pixantrone. We have a Neutral recommendation on the stock.
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