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Cyclacel CEO Explains How Sapacitabine Might Get Cleared For AML, Despite Phase III Failure

 
• By Emily Hayes

The company will talk to regulators in the US and Europe to see if the drug could be considered in elderly patients with low baseline peripheral white blood cells, who fared better than others in the failed SEAMLESS study.

Cyclacel Pharmaceuticals Inc. will soon be knocking on the doors of regulators in the US and Europe to see if they might consider approving sapacitabine for elderly patients with acute myeloid leukemia, despite missing the overall survival endpoint in the pivotal SEAMLESS study.

The Phase III SEAMLESS study enrolled 491 patients over the age of 70 with newly diagnosed AML, who were not candidates for intensive induction chemotherapy, to evaluate sapacitabine administered in...

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