Brukinsa Receives FDA Approval for Treatment of Waldenstrom’s Macroglobulinemia

The Food and Drug Administration (FDA) approved Brukinsa (zanubrutinib) for the treatment of adults with Waldenstrom’s macroglobulinemia, a type of non-Hodgkin lymphoma.

The approval is based on findings from the phase 3 ASPEN trial, according to a news release from BeiGene, the agent’s manufacturer. Previous data demonstrated that treatment with Brukinsa was associated with a very good partial response rate of 28% compared to 19% in patients who received Imbruvica (ibrutinib). Moreover, the overall response rate among patients who received Brukinsa was 78% and the event-free duration of response at 12 months was 94%. Event-free duration of response at 12 months among patients who were administered Imbruvica was 88% and the overall response rate was 78%.

“The approval of Brukinsa in Waldenstrom’s macroglobulinemia, which is the second therapy approved specifically for the treatment of this rare type of lymphoma, is positive news for patients,” said Pete DeNardis, Chair of the Board at the International Waldenstrom’s Macroglobulinemia Foundation, in the release. “Expanded treatment options offer new hope for those living with this disease and can potentially improve patient experience, especially oral therapies that can be given as a single agent.”

Common side effects that occurred in more than 20% of 779 patients included, but were not limited to, upper respiratory tract infection, rash, hemorrhage, musculoskeletal pain, bruising, diarrhea, pneumonia and cough.

“The ASPEN trial provided compelling evidence that Brukinsa is a highly active (Bruton tyrosine kinase [BTK]) inhibitor in Waldenstrom’s macroglobulinemia, and compared to the first-generation BTK inhibitor, showed improved tolerability across a number of clinically important side effects,” said Dr. Steven Treon, director of the Bing Center for Waldenstrom’s Macroglobulinemia Research at the Dana-Farber Cancer Institute in Boston, in the release. “The approval of Brukinsa provides an important new option for targeted therapy in Waldenstrom’s macroglobulinemia.”

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