Oncology company BeOne Medicines' investigational Bruton's tyrosine kinase (BTK) degrader, BGB-16673, has received priority medicines (PRIME) designation from the European Medicines Agency (EMA) to treat Waldenstrom’s macroglobulinemia (WM) in individuals previously treated with a BTK inhibitor.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) granted the designation based on the therapy’s novel mechanism and data showing its anti-tumour activity in B-cell malignancies.
BeOne Medicines chief regulatory affairs officer and senior vice-president Julie Lepin stated: “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.
“PRIME allows us to align early with the EMA on key evidence requirements and potentially accelerate our path to marketing authorisation of BGB-16673 for patients with relapsed or refractory Waldenstrom’s macroglobulinemia.”
BGB-16673 is an oral therapy from the company’s chimeric degradation activation compound platform.
It is developed to facilitate the degradation of BTK’s mutant and wild-type forms, including those that lead to resistance to BTK inhibitors in individuals with progressive conditions.
The therapy is the most advanced BTK protein degrader in clinical development, with a global clinical development programme.
The PRIME initiative aims to offer early support to medicine developers, enhancing development plans and expediting assessments to deliver therapies to individuals with unmet medical requirements.
CHMP also gave a positive opinion on the European Union orphan drug designation application for the therapy in this indication, with the final decision expected shortly.
BGB-16673 has also secured fast-track designation from the US Food and Drug Administration to treat adults with relapsed or refractory chronic lymphocytic leukaemia or small lymphocytic lymphoma, and with relapsed or refractory mantle cell lymphoma.
In July 2025, BeOne Medicines secured approval from the European Commission for Tevimbra (tislelizumab) to be used in combination with gemcitabine and cisplatin for adults with metastatic or recurrent nasopharyngeal carcinoma for whom curative surgery or radiotherapy is not an option.
