USA – The US Food and Drug Administration (FDA) has accepted Swiss drugmaker Roche’s bispecific antibody glofitamab for people with relapsed or refractory large B-cell lymphoma (LBCL).
Glofitamab is an investigational CD20xCD3 T-cell engaging bispecific antibody, for the treatment of adult patients with relapsed or refractory LBCL after two or more lines of systemic therapy.
It is part of Roche’s industry-leading CD20xCD3 T-cell engaging bispecific antibody clinical programme, which is the broadest and most advanced in lymphoma.
Roche, in a statement, said the FDA has accepted the company’s Biologics License Application (BLA) for glofitamab and it is expected to make a decision on approval of this novel cancer immunotherapy by 1st July 2023.
“The FDA will review the glofitamab BLA under the granted Fast Track Designation,” the multinational enterprise informed.
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 33.1% of patients having received prior CAR T-cell therapy.
“Results showed that 40.0% of patients achieved a complete response (CR; a disappearance of all signs of cancer), and 51.6% achieved an objective response (OR; the combination of CR and partial response, a decrease in the amount of cancer in their body),” Roche stated.
The multinational enterprise disclosed that data from the phase I/II study of glofitamab were submitted for review to the European Medicines Agency, and submissions to additional health authorities worldwide are ongoing.
“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,” the healthcare giant informed.
Roche underscored that LBCL is an aggressive (fast-growing) type of non-Hodgkin lymphoma (NHL) and is one of the most prevalent types of blood cancer among adults in the United States.
“Unfortunately, people with relapsed or refractory large B-cell lymphoma have a poor prognosis and desperately need additional therapies that are immediately available at the time of relapse,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development.
Dr. Garraway highlighted that glofitamab given for a fixed duration has shown impressive efficacy and long-term durability, with patients continuing to experience a complete remission after treatment has concluded.
Meanwhile, the Swiss corporation is working on a robust clinical development programme for glofitamab, investigating the molecule as a monotherapy and in combination with other medicines for the treatment of people with B-cell non-Hodgkin lymphomas.
“Additional studies are ongoing to investigate the molecule as a monotherapy and in combination with other medicines for the treatment of patients with B-cell NHLs, mantle cell lymphoma, and other blood cancers,” added Roche.
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