FDA fast-tracks BeiGene’s BGB-16673 for CLL/SLL

The US Food and Drug Administration (FDA) has granted fast-track designation to BeiGene’s BGB-16673 for the treatment of adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This designation is specifically aimed at patients who have already undergone at least two prior lines of therapy, including a BTK inhibitor (BTKi) and a B-cell lymphoma 2 (BCL2) inhibitor.

BGB-16673 is an orally available compound that targets Bruton’s tyrosine kinase (BTK) through a chimeric degradation activation mechanism (CDAC). The FDA’s decision to grant this fast-track status was motivated by the potential of BGB-16673 to address the unmet medical needs of patients with progressive forms of CLL and SLL.

Preliminary data from the ongoing first-in-human Phase I/II clinical trial indicate that BGB-16673 has demonstrated a tolerable safety profile and promising efficacy in heavily pretreated patients with relapsed or refractory CLL/SLL. So far, more than 300 subjects have participated in the trial, which spans 15 countries as part of a comprehensive global clinical development program.

The therapy aims to degrade both wild-type and multiple mutant forms of BTK. This includes mutations that often lead to resistance to BTK inhibitors in patients with progressive disease. This innovative approach could provide a significant alternative for patients who have limited treatment options after BTKi therapy.

Mehrdad Mobasher, Chief Medical Officer for Hematology at BeiGene, stated that the FDA’s fast-track designation supports their goal of efficiently developing BGB-16673. The compound is the first investigational drug from BeiGene's CDAC platform and is viewed as the most advanced BTK degrader currently in clinical trials. Mobasher believes that BGB-16673 not only enhances their leadership in hematology but also complements BRUKINSA (zanubrutinib), another key drug in their investigational hematology pipeline. He emphasized that BGB-16673 is well-positioned to become a crucial therapy for patients who progress after BTKi treatment and face limited therapeutic options.

In July 2024, BeiGene announced the opening of a new US biologics manufacturing and clinical research and development facility at the Princeton West Innovation Campus in Hopewell, New Jersey. This site is expected to play an instrumental role in providing innovative treatments to cancer patients worldwide, reinforcing BeiGene’s commitment to advancing cancer care.