The FDA has approved the supplemental new drug application (sNDA) submitted by BeiGene to use BRUKINSA® (zanubrutinib) along with obinutuzumab for treating adult patients dealing with relapsed or refractory (R/R) follicular lymphoma (FL) after having undergone at least two prior treatment lines.
BRUKINSA, which has already received Fast Track and Orphan designations for this specific purpose, is a small molecule inhibitor targeting Bruton’s tyrosine kinase (BTK). The drug is currently being assessed globally in a comprehensive clinical program, both as a monotherapy and in combination with other therapies, to address various B-cell malignancies effectively.
This development comes as a result of the Phase 2 ROSEWOOD study (NCT03332017), and it holds significant promise as BRUKINSA emerges as the initial Bruton’s tyrosine kinase inhibitor to exhibit notable efficacy against follicular lymphoma.
Given this success, BeiGene intends to proceed with regulatory submissions worldwide based on the compelling outcomes observed in the ROSEWOOD study. Dr. Mehrdad Mobasher, Chief Medical Officer of Hematology at BeiGene, emphasized the importance of this advancement, particularly in the context of limited treatment options for patients who have progressed beyond two lines of therapy, considering that follicular lymphoma is the most prevalent slow-growing non-Hodgkin lymphoma.
Source: BeiGene Announces FDA Acceptance of sNDA for Fifth BRUKINSA® Indication.
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