Posted by Michael Wonder on 12 Mar 2020
AbbVie receives European Commission approval of Venclyxto combination regimen for patients with previously-untreated chronic lymphocytic leukaemia
12 March 2020 - Approval is based on data from the Phase 3 CLL14 trial, which showed that patients treated with obinutuzumab plus one year of treatment with Venclyxto had superior progression-free survival and higher rates of undetectable minimal residual disease compared to patients receiving a standard of care chemoimmunotherapy regimen of obinutuzumab and chlorambucil.
AbbVie announced today that the European Commission (EC) has approved Venclyxto (venetoclax) in combination with obinutuzumab for the treatment of adult patients with chronic lymphocytic leukaemia who were previously untreated. The approval is valid in all 27 member states of the EU, as well as Iceland, Liechtenstein, Norway and the United Kingdom.
