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FDA Hold On Seattle Genetics' Trials Clouds CD33's Suitability for AML

 
• By Sten Stovall

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.

The suitability of CD33 as a target for acute myeloid leukemia has come into focus again after holds were placed on early trials with Seattle Genetics Inc.'s antibody drug conjugate vadastuximab talirine (SGN-CD33A).

The clinical holds, announced Dec. 27, followed the deaths of four patients treated with vadastuximab talirine along with allogeneic stem...

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