Posted by Michael Wonder on 03 Feb 2020
AbbVie receives positive CHMP opinion for Venclyxto as a chemotherapy-free combination regimen for patients with previously untreated chronic lymphocytic leukaemia
31 January 2020 - If approved by the European Commission, Venclyxto plus obinutuzumab would be the first chemotherapy-free, combination regimen given with a fixed duration for patients with previously untreated chronic lymphocytic leukaemia.
AbbVie announced today that the CHMP of the EMA has granted a positive opinion for Venclyxto (venetoclax) in combination with obinutuzumab for the treatment of patients with chronic lymphocytic leukaemia who were previously untreated. The positive CHMP opinion is a scientific recommendation for marketing authorisation to the European Commission, which is expected to deliver its final decision in the first half of 2020.
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.
