AbbVie Says FDA Lifts Partial Hold on Phase 3 Trial
June 24 2019 - 9:38AM
Dow Jones News
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 michael.dabaie@wsj.com
(END) Dow Jones Newswires
June 24, 2019 09:23 ET (13:23 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
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