Health Canada Approves Roche's Columvi® (glofitamab) as the First Bispecific Antibody in Canada for Relapsed or Refractory Diffuse Large B-Cell Lymphoma after Initial Therapy

• DLBCL is an aggressive cancer with a high risk of progression meaning urgent and effective treatments are needed for people who relapse or have refractory disease
• This Columvi regimen offers an off-the-shelf and fixed-duration treatment option for those ineligible for transplant
• Approval is based on Phase III STARGLO study where Columvi in combination with chemotherapy showed a 41% reduction in the risk of death compared to Rituxan plus chemotherapy¹

MISSISSAUGA, ON, Aug. 21, 2025 /CNW/ - Hoffmann-La Roche Limited (Roche Canada) is pleased to announce that Health Canada has granted market authorization for Columvi® (glofitamab for injection) in combination with gemcitabine and oxaliplatin (GemOx) indicated for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma not otherwise (DLBCL NOS) specified who are not candidates for autologous stem cell transplant (ASCT).¹

With the approval, this Columvi combination is the first bispecific antibody regimen available for people with DLBCL in Canada whose cancer has returned or for those who did not respond to initial treatment. Columvi first received conditional marketing authorization in Canada in March 2023 for treatment after two or more lines of systemic therapy.¹

The Health Canada approval is supported by data from the pivotal Phase III STARGLO study. This randomized, open-label study compared Columvi plus gemcitabine and oxaliplatin (GemOx) to MabThera®/Rituxan® (rituximab) plus GemOx in patients with relapsed or refractory (R/R) DLBCL ineligible for autologous stem cell transplant (ASCT). At the primary analysis, the STARGLO study met its primary endpoint of overall survival, where results showed a 41% reduction in the risk of death (hazard ratio [HR]=0.59, p=0.011) for patients treated with Columvi plus GemOx compared to those treated with MabThera / Rituxan and GemOx. At an updated analysis, 58.5% of patients in the Columvi + GemOx arm achieve a complete response, compared to 25.3% in the R-GemOx arm.¹⁰ With two years of follow-up, Columvi plus GemOx sustained a clinically meaningful benefit in OS compared to R-GemOx.⁷ Safety of the combination appeared consistent with the known safety profiles of the individual medicines.¹

Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin lymphoma (NHL).⁵ It was estimated that in 2024, 11,700 Canadians were diagnosed with NHL, with 30-40% of these accounting for DLBCL cases.^2,8 Approximately four out of ten DLBCL patients will relapse after first-line treatment and the majority of patients who require subsequent lines of therapy have poor outcomes.⁶

"DLBCL is an aggressive and life-threatening form of lymphoma, leaving many patients in urgent need of additional treatment options," said Antonella Rizza, CEO, Lymphoma Canada. "The availability of novel therapies has the potential to address critical gaps in care and offer new possibilities for patients who face relapse or have limited options."

Whilst second-line treatment advances have been made, challenges with the accessibility of existing medicines and the aggressive nature of DLBCL underscore the urgent need for immediately available treatment options that can control the disease and improve survival.⁹

"Many patients with relapsed or refractory DLBCL in Canada are ineligible for potentially curative but intensive therapies, such as autologous stem cell transplantation or CAR T-cell therapy, due to advanced age, comorbidities, refractory disease, or geographic barriers. These patients currently face limited treatment options and poor outcomes with standard chemotherapy," said Robert Puckrin MD FRCPC, Arthur Child Comprehensive Cancer Centre & University of Calgary. "Glofitamab in combination with GemOx offers an off-the-shelf, fixed-duration approach with a novel T-cell engaging mechanism of action. With consistent safety data and survival benefits observed in clinical studies, Glofitamab-GemOx provides an important new option for patients with relapsed or refractory DLBCL."

"The approval of Columvi marks an important milestone for patients with relapsed or refractory DLBCL in Canada," said Reem Sorial, Hematology Franchise Head, Roche Canada. "By introducing this new option, we aim to support patients and healthcare professionals in addressing the challenges of managing this aggressive lymphoma."

Columvi is part of Roche's industry-leading CD20xCD3 bispecific antibody program. Roche Canada continues to be committed to advancing innovative therapies for individuals affected by lymphoma. In collaboration with provincial and territorial jurisdictions, we will work to facilitate timely access to this treatment through public and private drug plans. Our aim is to deliver tailored solutions that address the evolving needs of individuals with blood cancers and the healthcare systems that treat them.

About the Health Canada Authorization

The Health Canada authorization is based on results from the pivotal phase III STARGLO study, where Columvi in combination with GemOx demonstrated a statistically significant and clinically meaningful overall survival (OS) improvement versus MabThera®/Rituxan® (rituximab) and GemOx (R-GemOx) in people with R/R DLBCL. In the primary analysis (conducted after a median follow-up of 11.3 months), there was a 41% reduction in the risk of death in patients treated with Columvi plus GemOx versus R-GemOx (hazard ratio [HR]=0.59, 95% CI: 0.40-0.89, p=0.011). The Columvi combination also met its key secondary endpoints, with a 63% reduction in risk of disease worsening or death (progression-free survival, PFS) compared to R-GemOx (HR=0.37; 95% CI: 0.25–0.55, p<0.001). Follow-up analyses were conducted after all patients had completed therapy (median follow-up of 20.7 months), showing a 25.5 month median OS for people treated with the Columvi combination, nearly double what was seen for people treated with R-GemOx at 12.9 months (HR=0.62, 95% CI: 0.43-0.88). Additionally, more than twice as many patients experienced a complete response (58.5% versus 25.3% respectively, with a difference of 33.2% [95% CI: 20.9-45.5]). Safety of the combination was consistent with the known safety profiles of the individual medicines.¹

About Columvi® (glofitamab for injection)

In 2023, Columvi was approved as a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from follicular lymphoma (trFL), or primary mediastinal B-cell lymphoma (PMBCL), who have two or more lines of systemic therapy, and are ineligible to receive or cannot receive CAR-T cell therapy or have previously received CAR-T cell therapy. Columvi comes as a concentrate for solution for infusion, with each vial containing either 2.5 mg (in 2.5 mL) or 10 mg (in 10 mL) of Columvi. Each mL contains 1 mg of Columvi.¹

About Diffuse Large B-cell Lymphoma (DLBCL)

Lymphoma is the name for a group of blood cancers that develop in the lymphatic system and occur in two main types: Hodgkin lymphoma and non-Hodgkin lymphoma (NHL).^3,4 In particular, diffuse large B-cell lymphoma (DLBCL) is an aggressive (fast-growing) blood cancer and the most common form of NHL.⁵ While it is generally responsive to treatment in the frontline, as many as 40% of people will relapse or have refractory disease, at which time salvage therapy options are limited and survival is short.⁶

About Roche in Hematology

Roche has been developing medicines for people with malignant and non-malignant blood diseases for more than 25 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases.

About Roche Canada

At Roche Canada, patients and science are at the heart of everything we do. Our passion for science and our commitment to relentlessly pursuing the impossible for patients have made us one of the world's leading pharmaceutical, in-vitro diagnostics, and diabetes care management companies.

With our combined strength in diagnostics and pharmaceuticals, we're driving healthcare forward, while ensuring we deliver meaningful benefits for patients and sustainable healthcare systems. We are committed to creating a world where we all have more time with the people we love.

And we're adding our expertise in new areas, such as artificial intelligence, real world data collection and analysis and collaborating with many different sectors and industries.

Having the courage to reinvent ourselves and question the status quo is what patients and healthcare systems expect from Roche - and our commitment is as strong today as it was on the first day of our Canadian journey in 1931. Today, Roche Canada employs nearly 2,000 people at its offices in Mississauga, Ontario, in Laval, Quebec, and across the country from coast to coast to coast.

For more information, please visit www.RocheCanada.com or follow Roche Canada on LinkedIn.

Roche Group

Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world's largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

In recognising our endeavor to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceutical industry by the Dow Jones Sustainability Indices for the fifteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References 

¹ Columvi Product Monograph, 13 August, 2025.

² Canadian Cancer Society. Non-Hodgkin lymphoma statistics. Available at https://cancer.ca/en/cancer-information/cancer-types/non-hodgkin-lymphoma/statistics. Accessed on June 24, 2025.

³ Lymphoma Canada. What is Lymphoma. Available at https://www.lymphoma.ca/about-lymphoma/what-is-lymphoma/. Accessed on August 14, 2025

⁴ Lymphoma Canada. Types of Lymphoma. Available at https://www.lymphoma.ca/lymphoma/overview/types-of-lymphoma/. Accessed on August 14, 2025

⁵ Lymphoma Canada. Understanding NHL. https://www.lymphoma.ca/wp-content/uploads/2023/11/20231110-NHL_WEB.pdf. Accessed on June 24, 2025

⁶ New England Journal of Medicine. Diffuse Large B-Cell Lymphoma. Available at https://www.nejm.org/doi/full/10.1056/NEJMra2027612. Accessed on July 8, 2025

⁷ Gregory G, et al. GLOFITAMAB PLUS GEMCITABINE AND OXALIPLATIN (GLOFIT-GEMOX) IN PATIENTS WITH RELAPSED/REFRACTORY (R/R) DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL): 2-YEAR FOLLOW-UP OF STARGLO. Available at https://library.ehaweb.org/eha/2025/eha2025-congress/4160983/gareth.gregory.glofitamab.plus.gemcitabine.and.oxaliplatin.28glofit-gemox29.in.html. Accessed on August 13, 2025

⁸ Swerdlow SH, Campo E, Pileri SA, Harris NL, Stein H, Siebert R, et al. The 2016 revision of the World Health Organization classification of lymphoid neoplasms. Blood, J Am Soc Hematol. 2016;127(20):2375–90.

⁹ Fabbri N, Mussetti A and Sureda A. Second-line treatment of diffuse large B-cell lymphoma: Evolution of options. Semin Hematol 2023; 60(5): 305–312.

¹⁰ Abramson et al. Glofitamab plus gemcitabine and oxaliplatin (GemOx) versus rituximab-GemOx for relapsed or refractory diffuse large B-cell lymphoma (STARGLO): a global phase 3, randomised, open-label trial. The Lancet, Volume 404, Issue 10466, 1940 - 1954

SOURCE Hoffmann-La Roche Limited (Roche Canada)

Media Contact: Jennifer Mota, Communications Manager, Hoffmann-La Roche Limited (Roche Canada), 437-219-7806, [email protected]