FDA Accepts BeiGene's Supplemental New Drug Application for BRUKINSA® (Zanubrutinib)
Thursday, July 13, 2023
BeiGene has announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental new drug application (sNDA) for BRUKINSA® (zanubrutinib) in combination with obinutuzumab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after at least two prior lines of therapy.
BRUKINSA is a small molecule inhibitor of Bruton's tyrosine kinase (BTK) that has been developed by BeiGene scientists. It is currently being evaluated in clinical trials worldwide as a monotherapy and in combination with other treatments for various B-cell malignancies.
BRUKINSA is designed to provide complete and sustained inhibition of the BTK protein by optimising its bioavailability, half-life, and selectivity. It has shown efficacy in inhibiting the proliferation of malignant B cells in different disease-relevant tissues.
BRUKINSA has already received approval in more than 65 markets, including the United States, China, European Union, Great Britain, Canada, Australia, South Korea, and Switzerland, for selected indications. It is also under development for additional approvals globally.
Additionally, studies have shown that the combination of BRUKINSA (zanubrutinib) and obinutuzumab has exhibited a notable 50 percent decrease in the risk of disease progression or mortality when compared to the use of obinutuzumab alone.
