'Rapid' path for Curis' lead leukemia drug hits road­block with par­tial clin­i­cal hold af­ter pa­tient death

A pa­tient has died in a Phase I/IIa tri­al of Curis’ lead drug af­ter ex­pe­ri­enc­ing rhab­domy­ol­y­sis,  “among sev­er­al con­di­tions.” As a re­sult, FDA has slapped a par­tial clin­i­cal hold on the study.

The hold could throw the biotech’s plans for a po­ten­tial “rapid reg­u­la­to­ry path” of the drug in­to ques­tion. Just six weeks ago, Curis said it ex­pect­ed to meet with the FDA to dis­cuss the reg­is­tra­tional route for emavusert­ib as a monother­a­py in the first half of this year.

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