“UB-VV111 continues to lead the in vivo CAR T cell field in the US, and today’s announcement further reinforces its potential to address unmet needs in the treatment of those living with relapsed/refractory B-cell malignancies. This capability has the potential to address limitations with traditional ex vivo CAR T-cell therapy for patients and providers including high costs, long wait times, limited product availability, and difficult treatment. Drugs that receive fast track designation are eligible for more frequent meetings with the FDA, more frequent written communication from the FDA, eligibility for accelerated approval and priority review if relevant criteria are met, and rolling review. Umoja Biopharma Announces that UB-VV111 Receives FDA Fast Track Designation for Relapsed/Refractory B-Cell Malignancies. Fast Track.