AbbVie announced that the FDA has placed a partial clinical hold on all clinical trials using venetoclax in multiple myeloma. The hold was placed based on data from the Phase 3 BELLINI trial (a study for relapsed/refractory myeloma) in which a higher proportion of deaths were observed in the venetoclax arm compared to the control arm of the trial. No new patients will be enrolled in the trials until further analysis of the data is completed. Patients who are currently enrolled in studies and receiving benefit from the therapy may continue with treatment, after consultation with their physician.
This does not affect the clinical trials for chronic lymphocytic leukemia (CLL) or acute myeloid leukemia (AML).
“We are committed to patient safety and are thoroughly analyzing the results observed in the BELLINI trial. We will continue working with the FDA and worldwide regulatory agencies to determine appropriate next steps for the multiple myeloma program,” said Michael Severino, M.D., vice chairman and president, AbbVie. “We will continue to further the research and development of venetoclax and other therapies with the potential to transform the standards of care in blood cancers.”
Venetoclax is being developed by AbbVie and Roche and is jointly sold by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.