Research & Development
European Commission grants approval to AbbVie's and Roche's combination of Venclyxto and MabThera
5 November 2018 -

The European Commission has granted approval to United States-based AbbVie and Switzerland-based Roche for the combination of Venclyxto (venetoclax) and MabThera (rituximab) intended to treat relapsed/refractory chronic lymphocytic leukaemia in adult patients who had received at least one prior therapy, it was reported on Friday.

Venclyxto, which selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein, is being developed by AbbVie and Roche. MabThera, which is owned by Roche, is a monoclonal antibody that target cells having the CD20 marker on their surface.

The approval will enable more patients to be treated with Venclyxto in the second-line setting while giving healthcare providers the ability to prescribe the drug to a larger population of relapsed/refractory chronic lymphocytic leukaemia patients compared to the earlier approved indication of the drug as a monotherapy in the European Union. The approval of the combination includes 28 member states of the EU, along with Iceland, Liechtenstein and Norway. The product has received approval as a result of a positive opinion adopted by the European Committee for Medicinal Products for Human Use (CHMP) in September 2018 for the marketing authorisation application of the combination therapy for the intended indication, supported by the data from the MURANO phase 3 trial.



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