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FDA Approves First Non-Chemotherapy Combination for Waldenstrom Macroglobulinemia

The U.S. Food and Drug Administration (FDA) has approved the combination of Imbruvica® (ibrutinib) with Rituxan® (rituximab) for the treatment of Waldenstrom macroglobulinemia in adults. This is the first non-chemotherapy combination to be approved for treatment of the disease.1 Imbruvica and Rituxan are both targeted therapies. Imbruvica is a tyrosine kinase inhibitor, while Rituxan is a monoclonal antibody.2

The approval was based on findings from the iNNOVATE trial, a phase 3, double-blind, placebo-controlled trial that looked at 150 relapsed/refractory or treatment-naive patients (individuals who had not yet received any form of treatment) with Waldenstrom macroglobulinemia. Patients were randomized to receive either ibrutinib or a placebo, in addition to rituximab. 82% of the ibrutinib plus rituximab group achieved 30-month progression-free survival, compared with 28% of the group who took rituximab with a placebo.1 Measuring PFS is a common tool used to assess the effectiveness of different treatment options used in clinical trials.

Waldenstrom macroglobulinemia

Waldenstrom macroglobulinemia is a rare form of non-Hodgkin lymphoma. Waldenstrom macroglobulinemia starts in the B cells, where the Waldenstrom macroglobulinemia cells make large amounts of macroglobulin. High levels of macroglobulin can lead to symptoms like bleeding or nervous system issues, though Waldenstrom macroglobulinemia does not always cause symptoms.3

  1. FDA approves Imbruvica plus Rituxan for Waldenström’s macroglobulinemia. Healio. Available at
  2. Adult Non-Hodgkin Lymphoma Treatment (PDQ®)–Patient Version. National Cancer Institute. Available at
  3. What Is Waldenstrom Macroglobulinemia? American Cancer Society. Available at