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FDA Approves First Ever BTK Inhibitor to Treat Lymphoma Subtype

Rye Brook, N.Y., March 14, 2023 – The U.S. Food and Drug Administration approved zanubrutinib (Brukinsa®) in combination with obinutuzumab (Gazyva®) to treat adults whose follicular lymphoma has returned or progressed despite earlier treatment. 

The accelerated approval, which the FDA announced last week, was based on a higher and longer duration of response in patients treated with the combination of zanubrutinib and obinutuzumab compared to obinutuzumab alone.

“Follicular lymphoma becomes more aggressive and harder to treat with each relapse, making it imperative that we continue to find new treatments,” says Lee Greenberger, Ph.D., LLS Chief Scientific Officer. “Zanubrutinib belongs to class of drugs called BTK inhibitor, which have changed the landscape for many types of difficult to treat blood cancers.”

Blocking the BTK protein (Bruton’s Tyrosine Kinase) inhibits survival of malignant B cells, which drive many forms of non-Hodgkin lymphoma. Zanubrutinib alone was previously approved to treat four other forms of non-Hodgkin’s lymphoma: chronic lymphocytic leukemia/small lymphocytic lymphoma, Waldentsröm’s macroglobulinemia, mantle cell lymphoma and marginal cell lymphoma. 

BTK inhibitors have revolutionized the treatment of B-cell lymphomas, but as with many treatments, some cancers will eventually stop responding to certain drugs. There are now several BTK inhibitors available, as well as treatments that reduce BTK levels through different mechanisms. 

“It is particularly gratifying to see the approval of zanubrutinib plus obinutuzumab because, for the past 25 years LLS has funded the development of therapeutics—well before the approval of the first BTK inhibitor, ibrutinib, in 2013” said Dr. Greenberger.

LLS is currently supporting studies to determine the optimal sequence for use of these treatments, to understand how and why some cancers become resistant to treatment, and whether outcomes are improved by using drug combinations, like this zanubrutinib/obinutuzumab combination. 

“Follicular lymphoma is especially challenging for patients experiencing relapse,” says Dr. Greenberger. “This newly approved drug combination is a valuable addition to their treatment options.”

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Media Contact:
Ryan McDonald
Senior Manager, Medical and Science Communications
Ryan.McDonald@lls.org