FDA Greenlights BeiGene’s Brukinsa for Waldenstrom’s Macroglobulinemia

The U.S. Food and Drug Administration (FDA) approved BeiGene’s Brukinsa (zanubrutinib) for adults with Waldenstrom’s macroglobulinemia (WM). Brukinsa is a Bruton’s tyrosine kinase (BTK) inhibitor that is approved for mantle cell lymphoma and chronic lymphocytic leukemia.

“We are delighted by today’s FDA approval for Brukinsa in its second indication, offering a new treatment option with demonstrated efficacy and safety benefits for patients with Waldenstrom’s macroglobulinemia,” said Jane Huang, Chief Medical Officer, Hematology at BeiGene. “As shown in the ASPEN trial, Brukinsa can improve treatment outcomes for these patients and potentially make a positive impact on their lives.”

The approval was built on data from the Phase III ASPEN trial that compared Brukinsa to ibrutinib (Janssen and Pharmacyclic’s Imbruvica) in a total of 201 patients with MYD88 mutation. The primary efficacy endpoint was very good partial response (VGPR) in the overall intention-to-treat (ITT) population as evaluated by the independent review committee (IRC). The VGPR rate was 28% with Brukinsa compared to 19% with Imbruvica based on the modified Sixth International Workshop on Waldenstrom’s Macroglobulinemia (IWWM-6).

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