Partial Clinical Hold Lifted by FDA on Venetoclax Study in Multiple Myeloma
Posted: Tuesday, July 2, 2019
According to a recent statement by AbbVie, the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold placed on CANOVA (ClinicalTrials.gov identifier NCT03539744), a phase III trial evaluating venetoclax (Venclexta) in the investigational treatment of relapsed or refractory multiple myeloma. In the CANOVA trial, venetoclax is being studied in combination with dexamethasone versus pomalidomide in combination with dexamethasone in patients with relapsed or refractory multiple myeloma who have for the translocation (11;14) abnormality.
In March 2019, the FDA placed a partial clinical hold on all trials evaluating venetoclax in the investigational treatment of multiple myeloma, following a review of data from the phase III BELLINI trial (NCT02755597) of venetoclax with bortezomib and dexamethasone versus placebo in patients with relapsed or refractory multiple myeloma, in which a higher proportion of deaths was observed in the venetoclax arm compared with the control arm.
The FDA removed the partial clinical hold based upon agreement on revisions to the CANOVA study protocol, including new risk mitigation measures, protocol-specified guidelines, and updated futility criteria. Enrollment in the CANOVA trial may resume as determined by each participant site based on the approved protocol.
All other clinical trials evaluating venetoclax in patients with multiple myeloma remain on partial clinical hold while next steps continue to be evaluated with the agency. The partial clinical hold does not impact any of the approved indications for venetoclax, such as chronic lymphocytic leukemia or acute myeloid leukemia.
