08 Feb 10 Tough Questions Await Cell Therapeutics’ Cancer Drug

fda Cell Therapeutics’ experimental lymphoma drug pixantrone faces rough sledding from an FDA advisory committee after an agency staff review raised questions about the drug’s effectiveness and side effects. The news sent the company’s shares sharply lower.

One of the chief studies of the drug was supposed to involve 320 patients but only 140 were enrolled. Cell Therapeutics told the FDA it had trouble finding participants for the study because doctors preferred to use multiple chemotherapy drugs or supportive care, Reuters said, citing the FDA staff summary. Here’s the full FDA briefing document.

The study period was also cut short. The FDA said “a higher level of evidence is usually required in trials which discontinue prior to final analysis,” Dow Jones Newswires said.

Following the FDA staff comments, shares of Cell Therapeutics were trading down more than 25% around midday.

Cell Therapeutics hopes to sell the drug, pixantrone, under the brand name Pixuvri to treat non-Hodgkin’s lymphoma that has stopped responding to other treatments. The oncology advisory panel is to meet Wednesday. The FDA doesn’t have to follow the advice of its advisory panels, but it usually does.