The US Food and Drug Administration (FDA) has posted a safety statement to alert healthcare professionals and patients about the suspension of a clinical trial of bortezomib and low-dose dexamethasone with or without Venclexta (venetoclax).
The warning, which only relates to patients with relapsed and refractory multiple myeloma, comes after an analysis of data from the BELLINI clinical trial, which found that there was an increased risk of death for patients receiving the drug when it was combined with bortezomib and dexamethasone as compared to the control group.
The US regulators placed a partial clinical hold on all trials assessing the drug for multiple myeloma on March 19 this year, after a higher than expected number of patient deaths.
The FDA has also warned, however that the statement does not affect any of the approved indications for the drug for chronic lymphocytic leukemia (CLL) and acute myeloid leukemia (AML), or any trials outside of multiple myeloma.
“The FDA is actively examining the data from the trial and working directly with the drug’s sponsor to better understand the cause of the safety concerns. The FDA will take any additional actions as warranted to help ensure patients enrolled in this trial are protected and that doctors and clinical trial researchers understand the risks associated with this investigational use,” said FDA’s Centre for Drug Evaluation and Research director Janet Woodcock.
She continued, “Today’s alert underscores the importance of why new therapies are thoroughly studied to help ensure their benefits outweigh the risks to patients, and we will continue to carefully monitor clinical trials to help ensure patients are protected when safety concerns arise.”
