Biotechnology company BeiGene (NASDAQ:BGNE) (HKEX:06160) (SSE:688235) announced on Monday that the US Food and Drug Administration (FDA) has granted Fast Track Designation to BGB-16673 for the treatment of relapsed or refractory (R/R) chronic lymphocytic leukaemia or small lymphocytic lymphoma (CLL/SLL) who have been previously treated with at least two prior lines of therapy.
BGB-16673 is an investigational Bruton's tyrosine kinase (BTK) targeting chimeric degradation activation compound (CDAC).
The FDA's Fast Track Designation aims to expedite the development and review of drugs for serious conditions.
BGB-16673 has shown promising safety and efficacy in Phase 1/2 studies, offering a potential solution for patients with R/R CLL/SLL who have progressed on BTK inhibitors.
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