BeiGene announces FDA acceptance of sNDA for fifth Brukinsa indication

BeiGene announced the U.S. Food and Drug Administration FDA has accepted for review the Company’s supplemental new drug application sNDA for BRUKINSA or zanubrutinib in combination with obinutuzumab for the treatment of adult patients with relapsed or refractory R/R follicular lymphoma FL after at least two prior lines of therapy. BRUKINSA was previously granted Fast Track and Orphan designation for this indication. The FDA has assigned a target action date in the first quarter of 2024, under the Prescription Drug User Fee Act. “Follicular lymphoma is the most common slow-growing non-Hodgkin lymphoma, but there are limited treatment options for patients whose condition has progressed after two lines of therapy. We are therefore pleased that BRUKINSA is the first Bruton’s tyrosine kinase inhibitor to demonstrate efficacy in follicular lymphoma and plan to continue worldwide regulatory submissions based on the ROSEWOOD results,” said Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology. “Importantly, we are grateful to the people living with relapsed or refractory follicular lymphoma who chose to participate in the ROSEWOOD study.”