Glofitamab 10mg/10ml solution for infusion vials

Glofitamab is a full-length bispecific monoclonal antibody with affinity for both CD20 and CD3 surface antigens found on B- and T-cells, respectively. It has a 2:1 configuration, with bivalency towards CD20 and monovalency towards CD3, and works by recruiting T-cells directly to the surface of cancerous B-cells.[L45698][A258488]

Glofitamab was approved by Health Canada in March 2023 for the treatment of certain patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), becoming the first CD20/CD3 bispecific monoclonal antibody approved for DLBCL.[L45768] The most common type of non-Hodgkin lymphoma,[L45763] DLBCL is relatively sensitive to chemotherapy and generally responsive to first-line treatment regimens like CHOP ([cyclophosphamide], [doxorubicin], [vincristine], [prednisone])[L45763] - despite this, as many as 40% of patients will experience relapsed or refractory disease.[L45768][A258433] In the context of relapsed or refractory DLBCL, glofitamab provides an alternative treatment option for patients having failed other systemic therapies or for whom targeted therapies - such as CAR-T cell therapy - are inappropriate.

In June 2023, the FDA approved the use of glofitamab for the treatment of patients with relapsed or refractory DLBCL not otherwise specified or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy under accelerated approval based on response rate and durability of response.[L47047][L47052]

Glofitamab was granted conditional marketing authorization in July 2023 by the EMA for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. This approval is based on the positive results obtained from the phase I/II NP30179 study, where 35.2% of study participants achieved a complete response.[L47451]