Health Canada Approves Glofitamab with Chemotherapy for DLBCL

Health Canada has granted approval for the use of glofitamab (Columvi) in combination with chemotherapy agents gemcitabine and oxaliplatin (collectively known as GemOx) for adults suffering from relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT). This marks a significant milestone as glofitamab becomes the first bispecific antibody treatment available in Canada for patients whose cancer has either returned or failed to respond to prior therapies.

The approval is based on the results of the phase 3 STARGLO trial (NCT04408638), where the combination of glofitamab and GemOx demonstrated notable improvements in overall survival when compared to the standard treatment of rituximab (Rituxan) combined with GemOx. Data from the study showed that patients receiving the new regimen experienced a 41% reduction in the risk of death relative to those on the traditional treatment (hazard ratio, 0.59; 95% confidence interval, 0.40-0.89; P = .011).

Significant Findings from the STARGLO Trial

At the primary analysis with a median follow-up of 11.3 months, the findings indicated that patients on the glofitamab regimen achieved a median overall survival of 25.5 months, significantly higher than the 12.9 months seen in the rituximab group. Further analysis, which extended follow-up to a median of 20.7 months, reaffirmed these results, with a hazard ratio of 0.62 (95% CI, 0.43-0.88).

Additionally, the glofitamab plus GemOx therapy resulted in a 63% reduction in the risk of disease progression or death (HR, 0.37; 95% CI, 0.25-0.55; P < .001). The overall response rate was impressive, with 68.3% of patients in the glofitamab arm responding to treatment, compared to just 40.7% in the rituximab group. Complete responses occurred in 58.5% of those treated with glofitamab, illustrating a clear advantage over the 25.3% response in the comparison group.

Implications for Patients and Future Developments

The approval is particularly timely, as many patients with DLBCL face a dire need for effective treatment alternatives. “DLBCL is an aggressive and life-threatening form of lymphoma, leaving many patients in urgent need of additional treatment options,” stated Antonella Rizza, chief executive officer of Lymphoma Canada. She emphasized that the introduction of novel therapies like glofitamab could fill critical gaps in patient care and provide renewed hope for those experiencing relapse.

Despite this advancement in Canada, the approval process in the United States has encountered challenges. In July 2025, the FDA issued a complete response letter concerning the supplemental biologics license application for glofitamab plus GemOx for relapsed or refractory DLBCL patients. The letter indicated that the STARGLO data did not meet the necessary criteria for approval in the U.S. market.

The ongoing research and development surrounding glofitamab reflect a growing commitment to improving outcomes for patients with aggressive forms of cancer. As clinical trials continue, healthcare professionals remain optimistic about the potential of this treatment regimen to enhance survival rates and quality of life for individuals battling DLBCL. The safety profile of glofitamab plus GemOx has been consistent with prior studies, with no unexpected adverse effects reported, further solidifying its viability as a treatment option.