AbbVie Says FDA Lifts Partial Hold on Phase 3 Trial

By Michael Dabaie

AbbVie (ABBV) said the U.S. Food and Drug Administration lifted the partial clinical hold placed on Canova, a Phase 3 trial evaluating venetoclax for the investigational treatment of relapsed/refractory multiple myeloma.

The trial evaluates venetoclax in combination with dexamethasone versus pomalidomide in combination with dexamethasone in patients with relapsed/refractory multiple myeloma positive for the translocation (11;14) abnormality.

The FDA removed the partial clinical hold based upon agreement on revisions to the study protocol, including new risk mitigation measures, protocol-specified guidelines and updated futility criteria, AbbVie said.

All other clinical trials evaluating venetoclax in multiple myeloma remain on partial clinical hold, the company said. In March, AbbVie said the FDA placed a partial clinical hold on all trials evaluating venetoclax for multiple myeloma, following a review of data from the Phase 3 Bellini trial. Venetoclax is being developed by AbbVie and Roche (RHHBY).

Write to Michael Dabaie at [e-mail]

(END) Dow Jones Newswires

June 24, 2019 09:23 ET (13:23 GMT)

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