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Glofitamab granted approval by Health Canada for the treatment of R/R DLBCL
On August 21, 2025, Health Canada granted market authorization for glofitamab, a CD20×CD3 T-cell-engaging bispecific antibody, in combination with gemcitabine + oxaliplatin (GemOx), for the treatment of adult patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified who are ineligible for autologous hematopoietic stem cell transplant (auto-HSCT).1 This approval is based on results from the phase III STARGLO trial (NCT04408638).1
STARGLO
The multicenter, open-label, randomized phase III STARGLO trial assessed the efficacy and safety of glofitamab + GemOx vs rituximab + GemOx (R-GemOx) in patients with R/R DLBCL who have received ≥1 prior line of therapy and who are not candidates for auto-HSCT or who have received ≥2 prior lines of therapy.1 In the primary analysis, the primary endpoint of overall survival was met, with a 41% reduction in the risk of death with glofitamab + GemOx vs R-GemOx (hazard ratio, 0.59; p = 0.011). Updated results showed an improved complete response rate with glofitamab + GemOx vs R-GemOx (58.5% vs 25.3%).1 During the European Hematology Association (EHA) 2025 Congress, June 12–15, 2025, Milan, IT, Gareth Gregory presented 2-year follow-up results from the STARGLO trial.
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