AbbVie's Venclyxto Gets CHMP Positive Opinion
January 31 2020 - 7:41AM
Dow Jones News
By Chris Wack
AbbVie (ABBV) said Friday the Committee for Medicinal Products
for Human Use of the European Medicines Agency has granted a
positive opinion for Venclyxto venetoclax in combination with
obinutuzumab for the treatment of patients with chronic lymphocytic
leukemia who were previously untreated.
The company said the European Commission is expected to deliver
its final decision in the first half of 2020.
AbbVie said if Venclyxto is approved by the EC, the venetoclax
and obinutuzumab combination would be the first chemotherapy-free
option for treatment-naive patients with chronic lymphocytic
leukemia where dosing can be completed in one year.
The CHMP positive opinion is based on results from the Phase 3
CLL14 clinical trial, which evaluated the efficacy and safety of
Venclyxto in combination with obinutuzumab compared with
chlorambucil in combination with obinutuzumab. The primary endpoint
was progression-free survival as assessed by an investigator.
Venclyxto is being developed by AbbVie and Roche (RHHBY). It is
jointly commercialized by AbbVie and Genentech, a member of the
Roche Group, in the U.S. and by AbbVie outside of the U.S.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
January 31, 2020 07:26 ET (12:26 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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