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.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
2 mins