Posted by Michael Wonder on 22 Sep 2018
AbbVie receives positive CHMP opinion for a novel, chemotherapy-free combination of Venclyxto (venetoclax) with rituximab as a treatment with a fixed duration for patients with chronic lymphocytic leukaemia who have received at least one prior therapy
21 September 2018 - The positive opinion is based on the MURANO Phase 3 clinical trial, in which Venclyxto plus rituximab met the primary endpoint of prolonged progression-free survival and the majority of patients achieved undetectable minimal residual disease in the peripheral blood, compared to a standard of care chemo-immunotherapy regimen of bendamustine plus rituximab.
AbbVie announced today that the CHMP of the EMA has granted a positive opinion for Venclyxto (venetoclax) in combination with rituximab for the treatment of patients with relapsed/refractory chronic lymphocytic leukaemia who have received at least one prior therapy.
The positive CHMP opinion is a scientific recommendation for marketing authorisation to the European Commission, which will deliver its final decision, valid in all 28 member states of the European Union, as well as Iceland, Liechtenstein and Norway.
