FDA warns about the risks associated with the investigational use of Venclexta (venetoclax) - Drug Information Update

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The U.S. Food and Drug Administration is alerting health care professionals, oncology clinical investigators and patients about the risks associated with the investigational use of Venclexta (venetoclax) for the treatment of patients with multiple myeloma based on data from a clinical trial. Venclexta is not approved for the treatment of multiple myeloma. FDA reviewed data from the BELLINI clinical trial (NCT02755597, Study M14-031) evaluating the use of Venclexta combined with bortezomib, a proteasome inhibitor, and dexamethasone in patients with multiple myeloma. The interim trial results demonstrated an increased risk of death for patients receiving Venclexta as compared to the control group. On March 6, 2019, the FDA required no new patients be enrolled on the Bellini trial. Patients who are receiving clinical benefit can continue treatment in the trial after they reconsent.  This statement does not apply to patients taking Venclexta for an approved indication. Patients taking Venclexta for an approved indication should continue to take their medication as directed by their health care professional. Venclexta is safe and effective for its approved uses. For more information, please visit: Venclexta.