The US Food and Drug Administration (FDA) has granted fast-track designation for BeiGene’s BGB-16673 to treat adults with relapsed or refractory chronic lymphocytic leukaemia or small lymphocytic lymphoma (CLL/SLL).

BGB-16673 is designed for patients who have undergone a minimum of two prior lines of therapy, including a BTK inhibitor (BTKi) and a B-cell lymphoma 2 (BCL2) inhibitor.

It is an orally available Bruton’s tyrosine kinase (BTK) targeting chimeric degradation activation compound (CDAC).

The FDA's decision was influenced by the potential of BGB-16673 to meet the unmet medical needs of patients with progressive CLL/SLL.

Data from the ongoing first-in-human Phase I/II trial have shown that BGB-16673 has a tolerable safety profile and promising efficacy in heavily pretreated R/R CLL/SLL patients.

More than 300 subjects have been treated so far across 15 countries as part of the global clinical development programme for BGB-16673.

The therapy is designed to induce degradation of both wildtype and multiple mutant forms of BTK, including those mutations that commonly confer resistance to BTK inhibitors in patients with progressive disease.

BeiGene haematology chief medical officer Mehrdad Mobasher stated: “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 haematology leadership and complements BRUKINSA (zanubrutinib), the backbone for our investigational haematology 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.”

In July 2024, BeiGene  announced the opening of its new US biologics manufacturing and clinical research and development facility at Hopewell, New Jersey.

Situated at the Princeton West Innovation Campus, the site is set to play a crucial role in providing innovative medicines to cancer patients worldwide.