Genentech, a member of Swiss drug major Roche Group (RHHBY), announced Friday that the U.S. Food and Drug Administration has accepted its Biologics License Application or BLA and granted Priority Review for glofitamab to treat people with relapsed or refractory large B-Cell lymphoma.
Glofitamab is 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, i.e., fast-growing type of non-Hodgkin's lymphoma or NHL.
The FDA is expected to make a decision on approval of the novel cancer immunotherapy by July 1, 2023.
If approved, the company expects glofitamab to 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.
The BLA is based on positive data from the pivotal Phase I/II NP30179 study, which included patients who had previously received multiple courses of therapy, with 85.1% of patients refractory to their most recent therapy and about one-third having received prior CAR T-cell therapy.
Genentech said the FDA will review the glofitamab BLA under the granted Fast Track Designation. Data from the Phase I/II NP30179 study of glofitamab were submitted for review to the European Medicines Agency, and submissions to additional health authorities worldwide are ongoing.
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