BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the European Medicines Agency (EMA) has granted PRIority MEdicines (PRIME) designation to the Company’s investigational Bruton’s tyrosine kinase (BTK) degrader, BGB-16673, for the treatment of patients with Waldenstrom’s macroglobulinemia (WM) previously treated with a BTK inhibitor.
“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, Senior Vice President, Chief Regulatory Affairs Officer at BeOne. “PRIME allows us to align early with the EMA on key evidence requirements and potentially accelerate our path to marketing authorization of BGB-16673 for patients with relapsed or refractory Waldenstrom’s macroglobulinemia.”
In addition to the PRIME designation, the EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on the EU Orphan Drug Designation (ODD) application for BGB-16673 in WM. A final decision is anticipated in the coming weeks. The U.S. Food and Drug Administration (FDA) also granted Fast Track Designation to BGB-16673 for the treatment of adult patients with relapsed or refractory (R/R) chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL), and adult patients with R/R mantle cell lymphoma (MCL).
The EMA’s CHMP granted PRIME designation to BGB-16673 based on data demonstrating its novel mechanism and anti-tumor activity in B-cell malignancies. The CHMP recognized the limited treatment options available for WM patients post-BTK inhibitor therapy and acknowledged the strong biological rationale and promising clinical data for BGB-16673 in this setting, thereby demonstrating the potential to address the unmet medical need.
The PRIME initiative, launched by the EMA in 2016, provides early, proactive, and enhanced regulatory support to developers of promising medicines. It is designed to optimize development plans and accelerate evaluation, helping innovative therapies reach patients with unmet medical needs faster.
