FDA panel slaps down Cell Therapeutics' pixantrone

Seattle-based Cell Therapeutics took its case for the cancer drug pixantrone to an expert panel convened by the FDA this morning. And the developer got slapped down hard, losing a unanimous vote against a marketing recommendation.

CEO Jim Bianco stressed that the developer had worked closely with the FDA in designing a clinical trial for pixantrone for the treatment of relapsed/refractory aggressive non-Hodgkin's lymphoma, which he believes underscored the drug's "favorable benefit to risk profile." But earlier the FDA's Dick Pazdur told the experts that an agency analysis of pixantrone data had concluded that the drug group did not demonstrate a statistically significant improvement over the control arm. And only 140 of a planned 320 patients were recruited for the trial, with a mere eight U.S. patients in the study. "That was brutal," blogged TheStreet's Adam Feuerstein after Pazdur had finished talking.

"I don't see this as a well designed or well executed study. The evidence speaks against it," noted panel member Wyndham Wilson. 

Cell Therapeutics had a lot riding on today's vote. The company's auditor recently handed management a going-concern notice and its battered stock closed on Friday at 91 cents a share. Once trading resumed on CTIC this afternoon, its shares immediately shed 59 percent of their remaining value.

The final decision on pixantrone lies with the FDA, but it's extremely unlikely that the agency would overrule a unanimous vote against the drug.

- here's the Reuters story
- here's the story from Xconomy