Gazyva® IV Infusion 1000 mg revised to allow combination therapy with the Venclexta® Tablets 10 mg, 50 mg, and 100 mg for 1L CD20-positive CLL/SLL
This revision of the electronic package insert is based on the results of clinical studies evaluating the efficacy and safety of combination therapy with venetoclax and obinutuzumab for previously untreated chronic lymphocytic leukemia (including small lymphocytic lymphoma). These include a Japanese Phase II clinical study (M20-353) conducted by AbbVie GK and a global Phase III clinical study (CLL14/BO25323) conducted by Roche in cooperation with AbbVie Inc. and the German CLL Study Group from the University of Cologne.
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