Tuesday, September 23, 2014

More on Anti-CD20 Antibodies for Leukemia: The FDA and TG Therapeutics Reach Agreement on Phase III Trial Design

In my post of June 2, 2014, I questioned the significance of data that were hailed as evidence of the superiority of Gazyva, a new anti-CD20 antibody for the treatment of chronic lymphocytic leukemia (CLL) as compared with Rituxan, the original anti-CD20 antibody used to treat CLL.  In that post, I focused on the difficulty of meaningful conclusions about the comparative efficacy of two drugs, even when those drugs are studied head-to-head, when the two drugs were administered at very different doses.  Here is news on the development of another anti-CD20 antibody for the same indication, with the likely result being even more debate about the comparative effectiveness of these agents and the continuing absence of studies that would definitively answer the question.

See the Onclive story on the FDA and TG Therapeutics see http://www.onclive.com/web-exclusives/FDA-Grants-Special-Protocol-Assessment-to-Phase-III-UblituximabIbrutinib-Studyhttp://www.onclive.com/web-exclusives/FDA-Grants-Special-Protocol-Assessment-to-Phase-III-UblituximabIbrutinib-Study

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