FDA places hold on Venclexta for multiple myeloma

FDA issued a safety warning after it placed a partial clinical hold on all trials evaluating Venclexta venetoclax to treat multiple myeloma after an interim analysis showed that the drug led to a higher proportion of deaths in the Phase III BELLINI trial compared with placebo.

AbbVie Inc. (NYSE:ABBV) and Roche (SIX:ROG; OTCQX:RHHBY) market the drug in the U.S. to treat chronic lymphocytic leukemia (CLL) and acute myelogenous leukemia (AML). The hold and safety warning do not affect Venclexta's approved indications, according to AbbVie and FDA...