EC Grants Conditional Marketing Approval for Venclyxto in CLL

December 20, 2016

The European Commission granted a conditional marketing authorization to Venclyxto for the treatment of chronic lymphocytic leukemia in patients with certain genetic mutations.

The approval includes patients that are unsuitable for or have failed previous pathway inhibitor treatments or chemo-immunotherapy.

Venclyxto (venetoclax) is being co-developed by AbbVie and Roche; it is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S., and commercialized internationally by AbbVie. Venclyxto is marketed as Venclexta in the U.S., and received accelerated approval from the FDA in April.

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