Public company Precision BioSciences, Inc. earns key designation for leukemia treatment
The Durham drugmaker has received fast-track designation from regulators for its leukemia drug, meaning approval of the treatment could roll through its pipeline faster.
Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage biotechnology company dedicated to improving life with its novel and proprietary ARCUS® genome editing platform, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to Precision for PBCAR0191, the company’s lead investigational allogeneic chimeric antigen receptor (CAR T) cell therapy for the treatment of advanced B-cell precursor acute lymphoblastic leukemia (B-ALL).
“Fast Track Designation is intended to fill an unmet medical need by accelerating the development of agents for patients in need of potentially better therapeutic options,” said Chris Heery, MD, Chief Medical Officer of Precision BioSciences. “We continue to work toward demonstrating that PBCAR0191, as well as our other two allogeneic CAR T clinical programs, may play a role in the treatment paradigm of advanced malignancies in the future. We believe the balance of safety and efficacy plus the accessibility of allogeneic cell therapies may fill a void left by autologous CAR T therapies. This designation provides more flexibility as we attempt to identify the optimal patient population in which to seek regulatory approval.”
[Originally posted by Precision Biosciences — Aug 19, 2020]