7 November 2019 - Designation confirms significant unmet need remains in DLBCL.
Triumvira Immunologics today announced that the U.S. FDA has granted fast track designation for its novel T-cell therapy product TAC01-CD19 in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after at least 2 prior systemic therapies.
A Phase 1/2 study (TACTIC-19) conducted in patients with CD19-positive B-cell malignancies, including DLBCL, is expected to be initiated by the end of 2019.