Cell Therapeutics FDA Panel Primer: What You Need to Know to Be Ready Next Week

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because cancer is a life-threatening disease, it wouldn’t be a surprise if the panel asks tough questions of Cell Therapeutics about the safety of its drug.

Pixantrone has been studied in more than 400 patients overall, Jack Singer, Cell Therapeutics’ chief medical officer, said in a March interview. Singer noted that many of the patients had prior treatments that are toxic to the heart, and that the drug’s “safety profile is about as good as one could hope for.”

One of the key questions the panel is likely to ask is about how long-lasting the remissions are for those patients whose tumors went away. This is one of the reasons many cancer trials are required to use the gold standard measurement of survival time as the primary goal. While complete tumor eradication can sometimes be a promising sign that a drug is working, it’s not always reliable, because cancer can bounce back fast and kill people. Cell Therapeutics doesn’t have statistically significant evidence that shows its drug actually helps patients live longer than some other generic chemotherapy.

If the FDA panel starts pounding the table for that kind of survival data, and says Cell Therapeutics needs to run more trials with a lot more patients before it can get the green light for pixantrone, then this will be a painful blow for the company’s supporters. If Cell Therapeutics can persuade the panel that its data is good enough, then February 10 will be the first day of rebirth at Cell Therapeutics. Either way, the daily stock chart—in which many of those 574 million shares are sure to change hands—will say it all.

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