Question marks over AbbVie/Roche’s venetoclax after safety scare

AbbVie and Roche have stopped recruiting patients for all multiple myeloma trials involving the drug venetoclax after a higher proportion of deaths were observed in patients receiving it than in a trial’s control arm. AbbVie, which is developing the drug in partnership with Roche, said the partial clinical hold follows a review of data from the ongoing phase 3 BELLINI trial, in relapsed/refractory multiple myeloma. Following a ruling from the FDA, no new patients will be enrolled in any studies of venetoclax for multiple myeloma until further analysis of the data is completed. This action does not impact any of the approved indications for venetoclax, such as chronic lymphocytic leukemia (CLL) or acute myeloid leukemia (AML), and is limited to investigational clinical trials in multiple myeloma.