ABBVIE said the European Commission granted conditional marketing authorization for Venclyxto (venetoclax) monotherapy for the treatment of chronic lymphocytic leukaemia in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor; and for the treatment of CLL in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor.
The EC approved Venclyxto as a first-in-class, oral, once-daily medicine that selectively inhibits the function of the BCL-2 protein.BCL-2 prevents the natural death of cells, including CLL cells.
Venclyxto is being developed by AbbVie and Genentech, a member of the Roche Group. It is jointly commercialized by the companies in the U.S. and by AbbVie outside of the U.S.
The 17p deletion, a genomic alteration in which a part of chromosome 17 is absent, is found in 3 to 10 percent of previously untreated CLL cases and up to 30 to 50 percent of relapsed or refractory CLL cases.A TP53 mutation occurs in 8 to 15 percent of patients at first-line treatment and up to 35 to 50 percent of cases in refractory CLL. Those with the 17p deletion or TP53 mutations often have a particularly poor prognosisand a median life expectancy of less than two to three years with current standard-of-care regimens.
Conditional marketing authorization is granted to medicines that address an unmet medical need, where the benefit of its immediate availability to patients outweighs the risk of limited data availability, and where comprehensive data will be provided.
In April 2016, FDA granted accelerated approval of Venclexta (venetoclax) tablets for the treatment of patients with CLL with 17p deletion, as detected by an FDA-approved test, who have received at least one prior therapy.
The FDA approved this indication under accelerated approval based on overall response rate, and continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial.
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