Deaths spur par­tial hold for Xen­cor’s CD3 bis­pe­cif­ic for leukemia, part­nered with No­var­tis in $2.5B deal

Re­searchers at Xen­cor have slammed the brakes on re­cruit­ing more pa­tients for an ear­ly-stage study of XmAb14045, a CD123 x CD3 bis­pe­cif­ic an­ti­body in the race for acute myeloid leukemia. 

The com­pa­ny says that the FDA dropped the hold on them af­ter they tracked 2 deaths in the study that could be linked to the bis­pe­cif­ic — one from cy­tokine re­lease syn­drome and an­oth­er from acute pul­monary ede­ma fol­low­ing sev­er­al dos­es. The CRS case was com­pli­cat­ed by the pa­tient’s de­ci­sion to with­draw from the study, ac­cord­ing to the com­pa­ny.

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.