BeiGene announces MHRA granted marketing authorization for BRUKINSA

BeiGene announced that the Medicines and Healthcare products Regulatory Agency, MHRA, has granted marketing authorizations for BRUKINSA in Great Britain for both the treatment of adult patients with chronic lymphocytic leukemia, CLL, and the treatment of adult patients with marginal zone lymphoma, MZL, who have received at least one prior anti-CD20-based therapy. The MHRA authorization for CLL is based on two global Phase 3 clinical trials: SEQUOIA, comparing BRUKINSA against bendamustine plus rituximab in patients with previously untreated CLL, and ALPINE, comparing BRUKINSA against IMBRUVICA in patients with relapsed/refractory CLL. "As a BTK inhibitor designed to maximize BTK occupancy and minimize off-target binding, we believe BRUKINSA presents a very promising treatment option for eligible patients with MZL and CLL," said Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene.