BeiGene’s BGB-16673 Receives FDA Fast Track Designation for CLL/SLL

BeiGene, Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to BGB-16673, an orally available investigational Bruton’s tyrosine kinase (BTK) targeting chimeric degradation activation compound (CDAC), for adult patients with relapsed or refractory (R/R) chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have been previously treated with at least two prior lines of therapy, including BTK inhibitor (BTKi) and B-cell lymphoma 2 (BCL2) inhibitor.

The FDA’s Fast track designation is aimed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to patients earlier.

“When disease progression for patients on BTK inhibitors occurs, there is a need for BTK-targeting agents with a different mode of action given the centrality of this pathway in CLL/SLL. BTK-protein degradation with our BTK CDAC (BGB-16673) may address this unmet need,” said Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology. “The FDA’s Fast Track Designation supports our goal of efficiently developing BGB-16673 for these patients, the first investigational drug from our CDAC platform. We believe BGB-16673 strengthens our hematology leadership and complements BRUKINSA (zanubrutinib), the backbone for our investigational hematology pipeline. BGB-16673 is the most advanced BTK degrader in the clinic and is well-suited to become an important therapy for patients progressing after BTKi who have limited options.”

The designation was requested based on the potential for BGB-16673 to address an unmet medical need for patients CLL/SLL whose disease has progressed. Data from ongoing first-in-human Phase 1/2 (NCT05006716) presented at the European Hematology Association 2024 Hybrid Congress in June highlighted the tolerable safety and promising efficacy in heavily pretreated patients with R/R CLL/SLL. More than 300 patients have been treated to date in 15 countries across the BGB-16673 global clinical development program.