New Cancer Therapy:
The US Food and Drug Administration (FDA) has granted the review of glofitamab. It will be reviewed for relapsed or refractory large B-cell lymphoma on a priority basis.
The decision for the priority review of glofitamab is granted for adults. Patients suffering from relapsed or refractory (R/R) large B-cell lymphoma (LBCL) after two or more lines of systemic therapy.
If the drug gets approved it would be the first fixed duration cancer immunotherapy. Additionally, an off-the-shelf CD20xCD3 T-cell engaging bispecific antibody available for individuals with lymphoma. The FDA is expected to make a decision on approval by mid-2023.
Dr Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development stated: “Even for patients whose cancer is rapidly progressing, administering glofitamab for a fixed duration shows impressive efficacy and long-term durability. Furthermore, this is applicable for patients who are continuously experiencing a complete remission after treatment has concluded.”
Data of Phase I/II study of glofitamab
Positive data was obtained from the Phase I/II study NP30179 trial. 85.1 percent of the patients of the trial had refractory to their most recent therapy . Additionally, about 33.1 percent had received prior CAR T-cell therapy.
Further, trial data showed that glofitamab has helped 40 percent of heavily pre-treated large B-cell lymphoma patients to achieve a complete response (CR). Moreover, 51.6 percent (n=80/155) achieved an objective response (OR; the combination of CR and partial response, a decrease in the amount of cancer in their body).
An earlier study cut-off showed that glofitamab given as a fixed-duration treatment results in early and durable complete remissions. The study was presented at the American Society of Hematology 2022 Annual Meeting.
Further, it was also published in the New England Journal of Medicine in December 2022. Additionally, It showed that most of the patients who achieved a CR at the end of treatment experienced durable responses.
Therefore, the FDA will review the glofitamab BLA under the granted Fast Track Designation. Finally, the analysis will be done based on the data from the Phase I/II NP30179 study which were submitted for review to the European Medicines Agency (EMA).
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