WASHINGTON, (June 20, 2025) – The U.S. Food and Drug Administration has approved a new tablet formulation of zanubrutinib (Brukinsa®) which is used to treat chronic lymphocytic leukemia and four types on non-Hodgkin lymphoma (follicular, mantle cell, marginal zone and Waldenström’s macroglobulinemia). The new formulation will be available starting in October 2025.
“With this new formulation, patients have the option to take two easier-to-swallow tablets instead of the previous four capsules,” says Lore Gruenbaum, Ph.D., LLS Chief Scientific Officer. “This is a benefit for all patients, especially those who have trouble swallowing. Oral targeted therapies like zanubrutinib have truly revolutionized blood cancer treatment, and now we’re seeing improvements that make them easier to take.”
Zanubrutinib is one of four Bruton’s tyrosine kinase (or BTK) inhibitors approved for use in the United States. These drugs work by targeting the activity of BTK, a protein that many blood cancers need to survive.
BTK inhibitors are second generation drugs that were developed after earlier Tyrosine kinase inhibitors (TKI). The first ever targeted therapy is a TKI called imatinib (Gleevec®), which was discovered and developed with LLS support, ushering in a new era in cancer treatment.
“Before targeted treatments, patients had limited options. Their best hope was chemotherapy, which is generally harder on the body and often less effective than targeted treatments,” says Dr. Gruenbaum. “The move to targeted treatment significantly improved quality of life for patients—and more amazing is that now we’re finding ways to improve on those treatments.”
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