The European Medicines Agency (EMA) has granted (PRIority MEdicines) designation to the investigational Bruton’s tyrosine kinase (BTK) degrader, BGB-16673, for the treatment of patients with relapsed or refractory Waldenstrom’s macroglobulinemia (WM).
The EMA’s Committee for Medicinal Products for Human Use (CHMP) also issued a positive opinion for BGB-16673 in WM according to press release from BeOne Medicines, the therapy’s manufacturer.
“This is the company’s first PRIME designation, marking a milestone for BeOne and providing early and enhanced interaction with the EMA as we advance BGB-16673,” said Julie Lepin, BeOne’s Chief Regulatory Affairs Officer, in the release.
The FDA also granted fast track designation to BGB-16673 for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia and small lymphocytic lymphoma, and adult patients with relapsed or refractory mantle cell lymphoma, according to the company’s press release.
