Rye Brook, N.Y., September 17, 2021 - The U.S. Food and Drug Administration (FDA) granted an accelerated approval to zanubrutinib (Brukinsa®), a Bruton tyrosine kinase (or BTK) inhibitor, for the treatment of adult patients with marginal zone lymphoma (MZL) whose disease has returned or worsened following prior treatment with at least one anti-CD20-based therapy.
MZL is a slow growing lymphoma with good overall survival rates. However, patients tend to relapse, and this may occur several times. This reinforces the need for additional treatment options, particularly for patients who have stopped responding to prior therapies. Roughly 10% of LLS research funding —$19.5 million in 2020 alone — is committed to slow growing lymphomas like MZL and follicular lymphoma (FL).
The approval of zanubrutinib was based, in part, on findings from the MAGNOLIA clinical trial, where 56% of patients with relapsed/refractory MZL responded to the drug and 20% of them had a complete response, where there was no detectable cancer. One year later, 85% of patients who responded were still in remission.
The most common adverse reactions that occurred in 30% or more of patients included abnormalities in blood tests, decreased neutrophil count, upper respiratory tract infection, decreased platelet count, hemorrhage, decreased lymphocyte count, rash and musculoskeletal pain. Notably, the incidence of off-target side effects, including atrial fibrillation, was reduced compared to another commonly used BTK inhibitor, ibrutinib.
The new approval comes just two weeks after zanubrutinib received an accelerated approval for the treatment of adult patients with Waldenström's macroglobulinemia, a rare non-Hodgkin lymphoma. Read more at the following link: https://lls.org/fda-approves-new-treatment-option-rare-form-lymphoma.