A cancer drug being jointly developed by Pharmacyclics and Janssen has been awarded a third breakthrough designation, the companies announced Monday (April 8). FDA in February granted the drug, ibrutinib, two breakthrough designations for the treatment of two types of lymphoma.
The third breakthrough designation for ibrutinib is for the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma patients with the deletion of the short arm of chromosome 17 based on data from pre-clinical and clinical studies, the companies said.
The breakthrough designation, enacted as part of the FDA Safety and Innovation Act, is intended to speed up the development and review of treatments for serious or life-threatening diseases that show potential in early clinical trials. As of mid-March, FDA had granted nine breakthrough designations. The designation announced Monday is the sixth to be made public.