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FDA Warns of Risks Associated With Investigational Use of Venetoclax in Multiple Myeloma

By: Sarah Jackson
Posted: Wednesday, March 27, 2019

On March 21, 2019, the U.S. Food and Drug Administration (FDA) issued a warning to alert health-care professionals, oncology clinical investigators, and patients about the risks associated with the investigational use of venetoclax (Venclexta) in the treatment of patients with multiple myeloma based on data from a clinical trial. Venetoclax is not approved in the treatment of multiple myeloma.

The FDA reviewed data from the BELLINI clinical trial (ClinicalTrials.gov identifier NCT02755597) evaluating the use of venetoclax in combination with the proteasome inhibitor bortezomib and dexamethasone in patients with multiple myeloma. The interim trial results demonstrated an increased risk of death for patients receiving venetoclax as compared with 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 at fda.gov.

This statement does not apply to patients taking venetoclax for the following approved indications:

  • Treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma, with or without 17p deletion, who have received at least one prior therapy;
  • Treatment in combination with azacitidine or decitabine or low-dose cytarabine for newly diagnosed acute myeloid leukemia in adults aged 75 years or older or who have comorbidities that preclude the use of intensive induction chemotherapy.

Patients receiving venetoclax for an approved indication should continue to take their medication as directed by their health-care professional. Venetoclax is safe and effective for its approved uses.

The FDA will be working directly with sponsors of venetoclax, 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.



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