Posted by Michael Wonder on 01 Nov 2018
AbbVie receives European Commission approval of Venclyxto (venetoclax) plus rituximab for the treatment of patients with chronic lymphocytic leukaemia who have received at least one prior therapy
1 November 2018 - The approval is based on the MURANO Phase 3 clinical trial, in which Venclyxto plus rituximab reduced the risk of disease progression or death by 83% and overall survival was prolonged compared to bendamustine in combination with rituximab, a standard of care chemo-immunotherapy regimen.
AbbVie announced today that the European Commission has approved the type-II variation application for Venclyxto (venetoclax) in combination with rituximab for the treatment of patients with relapsed/refractory chronic lymphocytic leukaemia (R/R CLL) who have received at least one prior therapy. This approval allows more patients to receive Venclyxto in the second-line setting and gives healthcare providers the ability to prescribe this medicine to a broader population of patients with R/R CLL than the previously approved indication for Venclyxto as monotherapy in the European Union. The approval is valid in all 28 member states of the EU, as well as Iceland, Liechtenstein and Norway.
