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FDA Warns of Risks Identified in a Clinical Trial for Multiple Myeloma

The U.S. Food & Drug Administration (FDA) has issued a partial clinical hold and safety warning regarding the investigational use of Venclexta® (venetoclax) for multiple myeloma. This safety warning does not apply to people taking Venclexta® for approved indications, including for acute myeloid leukemia (AML) and chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). Venclexta® is not currently approved for multiple myeloma.1,2

People with multiple myeloma currently enrolled in clinical trials involving Venclexta® should speak to their healthcare provider as soon as possible. Individuals deriving clinical benefit from these trials may be able to continue usage after discussing with their physician. The FDA has also suspended enrollment of new patients into multiple myeloma clinical trials of Venclexta® at this time.1,2

Clinical trial safety and the FDA

The partial clinical hold was issued due to data from the double-blind, phase 3 BELLINI trial, which evaluated the use of bortezomib and dexamethasone plus either Venclexta® or a placebo in certain patients with relapsed or refractory multiple myeloma.1

The safety of clinical trial participants is of paramount importance. The FDA can issue a complete or partial clinical hold on a trial in order to further evaluate the quality of the investigational treatment, assess the safety of the drug, and ensure the safety of trial participants. The drug sponsor is notified of the hold and is given the opportunity to address any issues. The FDA ultimately determines if the hold can be lifted and if the clinical trial can proceed.3

  1. FDA Warns about the risks associated with the investigational use of Venclexta in Multiple Myeloma. U.S. Food & Drug Administration. Available at https://www.fda.gov/Drugs/DrugSafety/ucm634120.htm. Accessed March 22, 2019.
  2. FDA places partial clinical hold on venetoclax trials for multiple myeloma. Healio HemOnc Today. Available at https://www.healio.com/hematology-oncology/myeloma/news/online/%7b59b9ed54-b771-4b3d-a6fe-39ec47d1b682%7d/fda-places-partial-clinical-hold-on-venetoclax-trials-for-multiple-myeloma. Accessed March 22, 2019.
  3. IND Application Procedures: Clinical Hold. U.S. Food & Drug Administration. Available at https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/investigationalnewdrugindapplication/ucm362971.htm. Accessed March 22, 2019.

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