The FDA has halted trials of a blood cancer drug sponsored by Seattle-based company CTI BioPharma. The agency said the drug may have a “detrimental effect” on patient survival.
Over 600 patients worldwide have taken part in the clinical trials.
CTI BioPharma, formerly known as Cell Therapeutics, had planned to seek FDA approval for its new blood cancer drug this year.
But this week, the FDA called for a “full clinical hold” on the company’s trials. The agency said an unspecified number of patients treated with the drug have died of brain hemorrhage, cardiac failure and cardiac arrest.
A spokeswoman for CTI BioPharma said the company can’t speak publicly, but it’s responding to the FDA’s recommendations.
Dr. Ruben Mesa is a hematologist and one of the drug’s clinical researchers. He’s based at the Mayo Clinic in Scottsdale, Arizona. He said he was surprised and taken aback when the hold was announced.
Mesa said patients with chronic leukemia are vulnerable to the conditions the FDA cited, so the drug isn’t necessarily to blame.
“They pass away from heart attacks, they pass away from bleeding complications because of the impacts of the disease. So it really is much more difficult than it seems to separate whether it’s related to the drug or to the disease,” he said.
But Mesa said the FDA is privy to more information than he is, and he hopes it will shed light on these questions.
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Stewart Lyman, a Seattle-based consultant for pharmaceutical companies, said the halt on research is bad news for CTI.
“They do not have a lot of drugs in their pipeline, and this particular one that the clinical hold affects is the one that I think they had been counting on to finally turn them into a successful company,” Lyman said.
He said the company has acquired and sold off various drugs in its 25 year history, but never had much revenue from them, and never successfully developed its own drug.
“The company has lost over $2 billion,” Lyman said. “And that’s a huge amount of money to lose in the biotech game and still find yourself in business.”
The company is headquartered near Seattle’s Olympic Sculpture Park. It has about 150 employees.