BeiGene announces FDA accelerated approval of BRUKINSA

BeiGene announced that the U.S. FDA has granted accelerated approval to BRUKINSA for the treatment of adult patients with relapsed or refractory follicular lymphoma, in combination with the anti-CD20 monoclonal antibody obinutuzumab, after two or more lines of systemic therapy. The indication is approved under accelerated approval based on response rate and durability of response, marking BRUKINSA’s fifth indication in B-cell malignancies in the U.S.