“There are currently no BTK inhibitors approved for MZL in Europe and with this positive opinion, we are one step closer to bringing forward a chemotherapy-free treatment option for this rare blood cancer. We look forward to a decision from the European Commission in the coming months,” said Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene. “We have undertaken a broad development program to evaluate BRUKINSA as a potential treatment for various B-cell malignancies in over 4,500 patients, which continues to generate evidence to support BRUKINSA as an effective and well-tolerated treatment option for blood cancer patients around the world.”