Posted by Michael Wonder on 27 Sep 2020
Precision BioSciences receives fast track designation from U.S. FDA for PBCAR269A, an investigational allogeneic CAR-T therapy for relapsed/refractory multiple myeloma
9 September 2020 - Precision BioSciences today announced the U.S. FDA has granted fast track designation to PBCAR269A for the treatment of relapsed/refractory multiple myeloma.
This is the company’s second allogeneic chimeric antigen receptor cell therapy to receive fast track designation for which the FDA previously granted orphan drug designation.
PBCAR269A is being evaluated in a Phase 1/2a multi-centre, non-randomised, open-label, parallel assignment, single-dose, dose-escalation, and dose-expansion study to evaluate the safety and clinical activity of PBCAR269A in adults with relapsed/refractory multiple myeloma.
