Cyclacel CEO Explains How Sapacitabine Might Get Cleared For AML, Despite Phase III Failure
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.
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FDA has placed clinical holds on several Phase I trials of vadastuximab talirine (SGN-CD33A) in acute myeloid leukemia after four patients died, clouding a field that is still in the shadow of Pfizer's failed Mylotarg.
First Phase III data for Novartis AG's acute myeloid leukemia (AML) therapy midostaurin has hematologists excited as the drug "inches forward" towards a market approval – opening up the door for possible evolution of standard of care for AML patients, which has been sealed shut for the past 30 years.
The oncology biotech is plowing ahead with its late-stage study of sapacitabine, despite unfavorable findings during an interim analysis.