Cell Therapeutics has a lot riding on February 10, the scheduled date for an advisory committee review of its lymphoma drug pixantrone, and TheStreet's Adam Feuerstein doesn't sound overly optimistic about its chances.
The agency experts will be looking over "positive" results already released by Cell Therapeutics, but Feuerstein lays out a series of skeptical questions.
- Will the FDA accept the data despite the fact that the company had enrolled only 40 percent of the patients originally planned?
- How reliable are the response rates unveiled in the EXTEND study?
- Did the patients enrolled in the comparator arm, which had only a 7.1 percent response rate, get the best drugs?
- And how sick were the patients enrolled?
Feuerstein has other questions, including one about the drug's toxicity, and he notes that the agency's panel has been mugging other blood cancer drugs recently. Final word: "Cell Therapeutics best be prepared for a brawl if it's going to walk away with a vote for approval."
Right or wrong, Feuerstein lays out an interesting analysis about what it takes to win an advisory committee vote on a new cancer therapy these days.
- check out the full analysis in TheStreet