Posted by Michael Wonder on 30 Sep 2025
Umoja Biopharma announces that UB-VV111 receives FDA fast track designation for relapsed/refractory B-cell malignancies
30 September 2025 - Umoja Biopharma announced today that the US FDA has granted fast track designation to UB-VV111 for the treatment of relapsed/refractory large B-cell Lymphoma following two or more lines of prior therapy and relapsed/refractory chronic lymphocytic leukaemia following two or more lines of prior therapy.
UB-VV111 is an investigational, off the shelf drug product that generates CD19-directed CAR-T cells in vivo, potentially addressing a range of shortcomings posed by traditional ex vivo autologous CAR T-cell therapies which limit broad patient access, including high manufacturing costs, long wait times, burdensome treatment processes, and limited product availability.
