FDA grants Brukinsa accelerated approval in relapsed or refractory marginal zone lymphoma – BeiGene

BeiGene, Ltd. announced that Brukinsa (zanubrutinib) has received accelerated approval from the FDA for the treatment of adult patients with relapsed or refractory (R/R) marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen.This accelerated approval is based on overall response rate (ORR). Continued approval for this indication may be contingent upon verification and description of clinical benefit […]

BeiGene receives positive CHMP opinion for Brukinsa for the treatment of adults with Waldenström’s macroglobulinemia

BeiGene has announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending approval of BRUKINSA (zanubrutinib) for the treatment of adult patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy or first-line treatment for patients unsuitable for chemo-immunotherapy. “Bruton’s tyrosine kinase (BTK) inhibitors have […]