Posted by Michael Wonder on 11 Sep 2018
Minimal residual disease negativity data, a measure of undetectable disease, added to Venclexta (venetoclax tablets) label
11 September 2018 - Minimal residual disease-negativity is defined as having disease at a threshold of less than one chronic lymphocytic leukaemia cell per 10,000 lymphocytes in the blood or bone marrow.
AbbVie today announced the U.S. FDA has expanded the label for Venclexta (venetoclax tablets) in combination with rituximab to include information about patients with previously-treated chronic lymphocytic leukaemia who achieved minimal residual disease-negativity in the Phase 3 MURANO trial.
Venclexta is being developed by AbbVie and Roche. It is jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S. Together, the companies are committed to BCL-2 research and to studying venetoclax in clinical trials across several blood and other cancers.
