FDA Grants Acalabrutinib Breakthrough Designation for CLL

Aug 14, 2019 – The FDA has granted a breakthrough therapy designation to acalabrutinib for the treatment of patients with chronic lymphocytic leukemia (CLL). The designation is based on findings from the interim analyses of the phase III ELEVATE-TN and ASCEND (ACE-CL-309) studies, which showed that acalabrutinib either as a single agent or in combination significantly reduced the risk of disease progression or death compared with standard regimens. Regarding safety, the … (leggi tutto)