TheStreet) -- Last week, I laid out in detail seven reasons why the U.S. Food and Drug Administration could decide to reject
(CTIC - Get Report) lymphoma drug pixantrone.
On Monday, the FDA posted a substantially negative assessment of pixantrone in advance of Wednesday's FDA advisory panel meeting. The FDA review hits on almost all seven of the pixantrone concerns and problems I raised.
|Cell Therapeutics' CEO Jim Bianco|
The entire FDA review of pixantrone is posted to the agency's web site.
Add it all up, and Cell Therapeutics faces a very difficult task convincing the FDA's panel of cancer experts to recommend pixantrone's approval as a treatment for patients with advanced, aggressive non-Hodgkin's lymphoma.Let's break down the issues I raised about pixantrone last week and see how that compares to what the FDA's reviewers said about the drug Monday: 1. Missing patients? Last week, I questioned whether the FDA would accept the "positive" results from the phase III "EXTEND" study of pixantrone given that Cell Therapeutics only enrolled 140 of a planned 320 patients. Recall that Cell Therapeutics has long claimed the FDA was OK with the smaller-than-expected enrollment in the study and that the study's statistical plan was adjusted accordingly. That turns out not to be true. Monday, the FDA wrote: "The planned sample size was 320. However, the study stopped early at an unplanned time point, due to poor accrual. A higher level of evidence is usually required in trials which discontinue prior to the final analysis. Based on the Rho family error spending function (Rho parameter = 2) used in the sponsor's statistical analysis plan and with 44% of planned enrollment, the significance level allocated for the submitted analysis would be 0.0096 (0.0014 based on the O'Brien-Fleming-type error spending function). Therefore, the submitted primary analysis would not be significant."