FDA grants priority review for glofitamab to treat large B-cell lymphoma and PDUFA date is expected on 1 July 2023- Genentech/Roche
Genentech, a member of the Roche Group announced that the FDA has accepted the company’s Biologics License Application (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 (R/R) large B-cell lymphoma (LBCL) after two or more lines of systemic therapy.
LBCL is an aggressive (fast-growing) type of non-Hodgkin’s lymphoma (NHL) 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, 2023. 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.
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