Genentech announces FDA acceptance of, grants priority review for glofitamab BLA

Genentech, a member of Roche, announced that the FDA has accepted the company’s biologics license application, or BLA, and granted priority review for glofitamab, an investigational CD20xCD3 T-cell engaging bispecific antibody, for the treatment of adult patients with relapsed or refractory, or R/R, large B-cell lymphoma, or LBCL, after two or more lines of systemic therapy. LBCL is an aggressive type of non-Hodgkin’s lymphoma and is one of the most prevalent types of blood cancer among adults in the U.S. The FDA is expected to make a decision on approval of this novel cancer immunotherapy by July 1. If approved, glofitamab would be the first fixed-duration, off-the-shelf CD20xCD3 T-cell engaging bispecific antibody available to treat people with an aggressive lymphoma who have previously received multiple courses of treatment.