BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235), a leading biopharmaceutical company, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for its novel compound BGB-16673. This investigational Bruton’s tyrosine kinase (BTK) targeting chimeric degradation activation compound (CDAC), known as a proteolysis-targeting chimera (PROTAC) product, represents a significant advancement in the treatment landscape for adult patients with relapsed or refractory (R/R) chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). The drug candidate is intended for patients who have exhausted at least two prior lines of therapy, including both BTK inhibitors (BTKi) and B-cell lymphoma 2 (BCL2) inhibitors.
The first-in-human Phase I/II clinical trial (NCT05006716) has demonstrated that BGB-16673 exhibits a tolerable safety profile and promising efficacy in treating R/R CLL/SLL patients who have undergone multiple lines of therapy, offering new hope for individuals in need of additional therapeutic options.- Flcube.com
