BeOne Medicines granted PRIME designation for BGB-16673 by EMA

BeOne Medicines (ONC) announced that the European Medicines Agency has granted PRIority MEdicines designation to the company’s investigational Bruton’s tyrosine kinase degrader, BGB-16673, for the treatment of patients with Waldenstrom’s macroglobulinemia previously treated with a BTK inhibitor. In addition to the PRIME designation, the EMA’s Committee for Medicinal Products for Human Use issued a positive opinion on the EU Orphan Drug Designation application for BGB-16673 in WM. A final decision is anticipated in the coming weeks. The U.S. FDA also granted Fast Track Designation to BGB-16673 for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma, and adult patients with R/R mantle cell lymphoma.