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FDA places partial hold on AbbVie's venetoclax multiple myeloma program

Posted on March 19, 2019 by Medtech[y] Staff


AbbVie announced this morning that the FDA has put a partial clinical hold on all clinical trials evaluating venetoclax, specifically for the investigational treatment of multiple myeloma.

The partial clinical hold does not affect venetoclax's approved indications such as acute myeloid leukemia (AML) or chronic lymphocytic leukemia (CLL). The action by the FDA is based on a data from the Phase 3 BELLINI trial, which is a study focused on relapsed/refractory multiple myeloma. During the trial, there were a higher proportion of deaths observed in the venetoclax arm compared to the control arm of the trial.

"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."

No new patients will be enrolled in venetoclax studies for multiple myeloma until this data is fully analyzed. Those patients already in the clinical trial and benefitting from the therapy will still be able to proceed after speaking with their physician.

AbbVie and Roche are the developers of venetoclax and is commercially sold by both AbbVie and Genentech.