Ahead of Wednesday's advisory committee meeting, FDA staffers have raised questions about Cell Therapeutics' lymphoma drug pixantrone. The developer is hoping to market the therapy, also known as Pixuvri, as a treatment for patients with non-Hodgkin's lymphoma that hasn't responded to other treatments.
The agency has concerns about both the drug's effectiveness as well as its safety profile. Difficulty recruiting patients led Cell Therapeutics (CTIC) to halted trial enrollment with only 40 percent of the patients originally planned for the trial. That's caused doubts about "the level of evidence necessary to draw conclusions from this Phase III study and the reliability of these conclusions," according to the agency's documents. The FDA also cited concerns about "substantial hematologic and cardiac toxicity" associated with pixantrone.
An expert panel will weigh the drug's effectiveness against its side effects, and a full decision is expected by April 23. Cell Therapeutics stock was down 36 percent this morning on the FDA's comments.