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Oral BTK inhibitor zanubrutinib receives FDA approval for treating chronic lymphocytic leukaemia

The United States Food and Drug Administration has recently approved US drug manufacturer BieGene’s oral next-generation BTK inhibitor, zanubrutinib for treating chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL).

The approval came after clinical trials, including the one conducted by Dana-Farber Cancer Institute that found that zanubrutinib was more effective at preventing disease progression and better tolerated than ibrutinib, the first-generation BTK inhibitor, the standard treatment available currently in patients with relapsed or refractory CLL or SLL patients.

Commenting on the development, Dr Jennifer R. Brown, director of the CLL Center at Dana-Farber Cancer Institute, said, “I am encouraged that zanubrutinib has been approved for adults with CLL and SLL and optimistic that many patients across the country will benefit from this approval.”

The phase 3 ALPINE randomized trial had previously shown that zanubrutinib achieved a better overall response rate (ORR) than ibrutinib. Dr Brown first presented the ALPINE results in a late-breaking oral session at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition, which showed that zanubrutinib-treated patients had a longer progression-free survival (PFS) at 29.6 months follow-up.

The two-year landmark PFS for zanubrutinib was 79.5%, compared to 67.3% for ibrutinib. The median PFS for zanubrutinib had not been reached at that point, while for ibrutinib, the median PFS was 35.0 months.

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The trial is the first head-to-head comparison of BTK inhibitors, where zanubrutinib demonstrated a better result in both response rate and progression-free survival, as well as a lower rate of treatment discontinuation at 26.3%, compared to 41.2% with ibrutinib, according to Dr Brown.

Dr Brown further said that discontinuation rates caused by heart disorders were lower in patients treated with zanubrutinib, including fewer cardiac events leading to death.

“Our findings also found that zanubrutinib led to fewer side effects and adverse events than ibrutinib, leading to a better quality of life for patients,” said Brown.

The trial results further showed that the rate of atrial fibrillation was lower with zanubrutinib at 5.2%, compared to 13.3% with ibrutinib, and there was zero grade five, usually fatal adverse events due to cardiac disorders with zanubrutinib versus six in patients treated with ibrutinib.

It may be recalled that the drug already received FDA approval for treating Waldenstrom macroglobulinemia, relapsed or refractory mantle cell lymphoma, and marginal zone lymphoma.

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