Health Canada has granted marketing authorization to Roche Canada for Columvi (glofitamab) in combination with gemcitabine and oxaliplatin chemotherapy — the first bispecific antibody regimen available in Canada for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant.

The authorization is supported by data from the Phase III STARGLO study, a randomized trial which demonstrated that the Columvi combination therapy resulted in a 41 percent reduction in the risk of death compared to a regimen of rituximab plus chemotherapy. Secondary outcomes from the trial indicated that the treatment nearly doubled median overall survival and more than doubled the rate of complete responses. The safety profile of this bispecific antibody regimen was reported to be consistent with the known effects of the individual drugs.

Image Credit: Roche Canada