BTK Degrader for R/R CLL/SLL Receives FDA Fast Track Designation

Pharmaceutical company BeiGene announced on Monday, August 26th, that the FDA granted Fast Track Designation to the BTK degrader called BGB-16673 for people with relapsed/refractory CLL/SLL who have received at least two prior lines of therapy. 

FDA Fast Track Designation is a program that accelerates the development and review of medicines intended to treat serious conditions and address unmet medical needs. 

“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. 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.” -Mehrdad Mobasher, M.D., M.P.H., BeiGene Chief Medical Officer, Hematology. 

Learn about how this new treatment option may help if you have already taken and are unable to re-take BTK inhibitors and venetoclax. 

What are BTK Degraders? 

BTK degraders like BGB-16673 are medicines taken as a pill by mouth indefinitely. They bind to and eliminate the BTK protein, helping stop the replication of CLL cells. Removing the BTK protein helps overcome CLL resistance previously caused by BTK inhibitors. Click here to learn more about BTK degraders. 

How Effective is BGB-16673 for Relapsed/Refractory CLL? 

Relapsed/refractory CLL refers to cancer that came back after or stopped responding to prior therapies. BGB-16673 is a treatment option for those who are no longer able to take BTK inhibitors or venetoclax (Venclexta, AbbVie). 

Although the CaDAnCe-101 study is in its early stages with follow-up data at only 4.6 months, findings from the study showed the following for how well the BTK degrader BGB-16673 helped people with relapsed/refractory CLL/SLL: 

• Out of the 43 people who took BGB-16673, on average, 72% had reduced signs and symptoms of CLL/SLL despite many of these individuals having high-risk disease features like del(17p), unmutated IGHV, and complex karyotype. 
• Common side effects included mild-to-moderate fatigue, bruising, anemia (decreased red blood cells), and diarrhea. Healthcare team members can provide supportive measures to reduce the impact of side effects. Click here to learn about how to manage the side effects of CLL therapies. 

How Can I Receive BGB-16673? 

The clinical trial administering BGB-16673 is still actively recruiting people with CLL/SLL who would like to join. Click here to review your eligibility to join the study. Click here to read answers to common questions about CLL clinical trials. 

Conclusion

In summary, BGB-16673 is a treatment that has been granted FDA Fast Track Designation for people with relapsed/refractory CLL/SLL. This means that the medicine’s review process to achieve FDA approval is being prioritized. Early data shows that it helps most patients achieve reduced signs and symptoms of the disease despite high-risk CLL features and prior resistance to BTK inhibitors. Continued data from the CaDAnCe-101 study will show how effective BGB-16673 may be in the long term. 

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Sources: 

• BeiGene’s BGB-16673 Receives U.S. FDA Fast Track Designation for CLL/SLL
• Preliminary Efficacy and Safety of the Bruton Tyrosine Kinase Degrader BGB-16673 in Patients With Relapsed or Refractory CLL/SLL: Results From the Phase 1 BGB-16673-101 Study