FDA Hold On Seattle Genetics' Trials Clouds CD33's Suitability for AML
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.
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Seattle Genetics will discontinue all trials of vadastuximab talrine, including the Phase III CASCADE trial in frontline older acute myeloid leukemia patients after a higher rate of deaths was seen.
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.
Unmet need in acute myeloid leukemia is very high, but that doesn't mean standards will be low for the many companies pursuing therapies in the space.