BeiGene's BGB-16673 Gets FDA Fast Track for CLL/SLL

BeiGene, Ltd., a global oncology firm, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its drug BGB-16673. This drug is an orally administered investigational compound targeting Bruton’s tyrosine kinase (BTK), designed for adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have undergone at least two prior lines of therapy, including BTK inhibitors and B-cell lymphoma 2 inhibitors.

The FDA's Fast Track Designation aims to expedite the development and review process of drugs that treat serious conditions and address unmet medical needs. This designation is intended to bring significant new drugs to patients more swiftly.

Dr. Mehrdad Mobasher, Chief Medical Officer for Hematology at BeiGene, emphasized the need for new BTK-targeting agents with a different mechanism of action, especially for patients whose disease progresses while on BTK inhibitors. He highlighted that BGB-16673, through BTK protein degradation, could meet this unmet need. The Fast Track Designation will aid in the efficient development of BGB-16673, which is the first investigational drug from BeiGene's chimeric degradation activation compound (CDAC) platform. Dr. Mobasher believes that BGB-16673 enhances BeiGene's position in hematology and complements their existing drug, BRUKINSA (zanubrutinib). BGB-16673 is currently the most advanced BTK degrader in clinical development and has the potential to become a crucial therapy for patients who progress after BTK inhibitor treatment.

The designation follows promising data from ongoing Phase 1/2 clinical trials. These trials, identified as NCT05006716, were presented at the European Hematology Association 2024 Hybrid Congress. The data indicated that BGB-16673 has a tolerable safety profile and promising efficacy in heavily pretreated patients with relapsed or refractory CLL/SLL. To date, more than 300 patients in 15 countries have participated in the global clinical development program for BGB-16673.

Chronic lymphocytic leukemia (CLL) is a life-threatening cancer predominantly affecting adults. It is a type of mature B-cell malignancy where abnormal leukemic B lymphocytes originate in the bone marrow and spread to peripheral blood and lymphoid tissues. CLL is the most common type of leukemia in adults, accounting for about one-third of new leukemia cases. In the U.S., approximately 20,700 new cases of CLL are expected to be diagnosed in 2024.

BGB-16673 is designed to induce the degradation of both wildtype and multiple mutant forms of BTK, including those that lead to resistance against BTK inhibitors in patients with progressive disease.

BeiGene is an international oncology company focused on developing innovative treatments that are more accessible and affordable for cancer patients worldwide. The company has a vast portfolio and advances its pipeline of novel therapeutics through its internal capabilities and collaborations. BeiGene is committed to significantly improving access to medicines for a larger patient population. The company employs over 10,000 people across five continents.