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On 19 March 2019, the U.S. Food and Drug Administration (FDA) placed a partial clinical hold on trials involving venetoclax (VENCLEXTA®/VENCYLXTO®) in the treatment of multiple myeloma (MM).
The decision is based on the results from the phase III BELLINI trial (NCT02755597) in relapsed/refractory MM (RRMM). In an FDA pre-planned analysis, there was a higher death rate (21% vs 11%) in the venetoclax arm compared to the placebo arm, of which 6.7% were determined to be treatment-emergent and over half were in the setting of progressive or refractory disease.
No new patients will be enrolled in studies using venetoclax until a further analysis is completed, though patients who are currently receiving venetoclax in clinical trials are permitted to continue treatment following a discussion with their treating physician. The FDA's decision is specific to the treatment of patients with MM and does not affect the use of venetoclax in other indications such as acute myeloid leukemia (AML).
Venetoclax is a BCL-2 inhibitor currently approved by the FDA for the treatment of AML and chronic lymphocytic leukemia or small lymphocytic leukemia. It is currently being investigated in the MM setting in various combination treatments.
Results given as venetoclax versus placebo arm
Further analysis of the data is ongoing with the results expected to be published in a peer-reviewed journal and presented during a future medical congress.
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