FDA Warns of Safety Concerns with Investigational use of Venclexta for Multiple Myeloma

PUBLISHED: Mar 22, 2019
Relevant to: All Healthcare Organizations

The U.S. Food and Drug Administration (FDA) 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. More information about the BELLINI clinical trial findings can be found by follow the link below.

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.

The FDA suspended enrollment in other ongoing multiple myeloma clinical trials of Venclexta. Patients who are receiving clinical benefit can continue treatment in these trials after they reconsent. FDA will be working directly with sponsors of Venclexta, as well as other investigators conducting clinical trials in patients with multiple myeloma, to determine the extent of the safety issue. The agency will communicate any new information as appropriate.

Health care professionals and patients are encouraged to report any adverse events or side effects related to the use of these products and any drugs to FDA’s MedWatch Adverse Event Reporting Program.

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