Zanubrutinib granted accelerated approval by the FDA for the treatment of patients with R/R MZL

On September 15, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to zanubrutinib for the treatment of adult patients with relapsed or refractory marginal zone lymphoma, who had at least one prior treatment with an anti–CD20-based regimen. Zanubrutinib is a next-generation, irreversible Bruton’s tyrosine kinase (BTK) small molecule inhibitor and is optimized for a higher specificity to improve efficacy and safety. BTK is instrumental in B-cell receptor signaling, a known driver in the development of marginal zone lymphoma.

The approval was based on clinical data from the single-arm, open-label, multicenter, phase II MAGNOLIA trial (NCT03846427), which you can read more about here for information on study design, patient characteristics, key outcomes, and adverse events. Additional supporting data came from the phase I/II trial of BGB-3111-AU-003 (NCT02343120), that investigated zanubrutinib in patients with B-cell malignancies. Continued approval might need verification of clinical benefit in a confirmatory trial.

Zanubrutinib has also been approved by the FDA for other indications including Waldenström’s macroglobulinemia, relapsed/refractory mantle cell lymphoma, and chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) by the Chinese National Medical Products Administration (NMPA).