Roche: EU agency recommends approval of Venclyxto

(CercleFinance.com) - A European Medicines Agency (EMA) panel on Friday recommended approval of Roche's Venclyxto to be used with MabThera for people with previously treated chronic lymphocytic leukaemia.


The EU Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Venclyxto, in combination with Roche's MabThera, for the treatment of people with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.

This means that Venclyxto can be expected to be approved by the European Commission in the near future.

In Europe, the incidence of all leukaemia is estimated to be almost 77,000 and CLL, the most common type, accounts for approximately one-third of new leukaemia diagnoses.

Venclyxto is being developed by AbbVie and Roche. It is jointly commercialised by AbbVie and Roche's Genentech in the United States, and sold by AbbVie elsewhere.

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