Shots:
- The EMA has granted PRIority MEdicines (PRIME) designation to BGB-16673 for the treatment of pts with Waldenstrom’s macroglobulinemia (WM), who previously were treated with a BTK inhibitor
- Designation was based on data showing BGB-16673’s novel ability to degrade both wild-type & mutant BTK forms, incl. resistance-linked variants, which demonstrated anti-tumor activity in B-cell malignancies
- Additionally, the CHMP has adopted a positive opinion on the Orphan Drug Designation application for BGB-16673 in WM, with a final decision expected in the coming wks.
Ref: BeOne Medicines | Image: BeOne Medicines| Press Release
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