AbbVie's Venclyxto Gets CHMP Positive Opinion

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 [e-mail]

(END) Dow Jones Newswires

January 31, 2020 07:26 ET (12:26 GMT)

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