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news.The US Food and Drug Administration (FDA) has accepted Roche’s Biologics License Application (BLA) and granted priority review for glofitamab.
Image: LBCL is a fast-growing kind of non-Hodgkin lymphoma (NHL). Credit: Nephron/ commons.wikimedia.org.
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Glofitamab is an investigational CD20xCD3 T-cell engaging bispecific antibody to treat adult patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) following two or more lines of systemic therapy.
LBCL is a fast-growing kind of non-Hodgkin lymphoma (NHL) and is a prevalent kind of blood cancer among adults in the US.
By 1 July 2023, the FDA is expected to take a decision on approval of this new cancer immunotherapy.
Following the approval, glofitamab is claimed to become the first fixed-duration, off-the-shelf CD20xCD3 T-cell engaging bispecific antibody for treatment of people with an aggressive lymphoma who earlier have got several courses of treatment.
Roche chief medical officer and head of global product development Levi Garraway said: “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.
“Even for patients whose cancer is rapidly progressing, 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.”
The BLA has been accepted by the regulatory agency based on positive data from the pivotal phase I/II NP30179 study, which included patients who had earlier got several courses of therapy, with 85.1% of patients refractory to their most recent therapy and about one-third (33.1%) having received prior CAR T-cell therapy.
The results indicated that 40% of patients achieved a complete response, and 51.6% achieved an objective response.
Furthermore, an earlier cut-off of data from the phase I/II study indicated that glofitamab given as a fixed-duration treatment led to early and durable complete remissions.
The most common adverse event was cytokine release syndrome (CRS), which was generally low grade. Most CRS events were linked associated with initial administration of glofitamab (in cycle 1).
The FDA will review the glofitamab BLA under the granted Fast Track Designation.
Data of the phase I/II NP30179 study of glofitamab was submitted for review to the European Medicines Agency, while submissions to further health authorities worldwide are ongoing.
