FDA lifts its hold on vadas­tux­imab talirine af­ter Seat­tle Ge­net­ics adds new safe­guards

A lit­tle more than two months af­ter the FDA put a clin­i­cal hold on ear­ly-stage work of its armed an­ti­body dubbed SGN-CD33A (vadas­tux­imab talirine) in acute myeloid leukemia fol­low­ing the deaths of 4 pa­tients, the agency has come back to lift the hold and give Seat­tle Ge­net­ics the green light to con­tin­ue.

Mov­ing for­ward, the biotech says it’s im­ple­ment­ing added risk mit­i­ga­tion mea­sures in all vadas­tux­imab talirine stud­ies, in­clud­ing “re­vised el­i­gi­bil­i­ty cri­te­ria and stop­ping rules for veno-oc­clu­sive dis­ease.”

Endpoints News

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.