European Commission Approves Columvi® (glofitamab) as First-Line Treatment for Relapsed or Refractory DLBCL in Europe
Basel, Switzerland, April 14, 2025 – Roche, a leading global pharmaceutical company, has announced that the European Commission has granted a marketing authorization for Columvi® (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified. This combination is the first bispecific antibody regimen available for people with DLBCL in Europe whose cancer has returned or for those who did not respond to initial treatment.
In July 2023, Columvi received a conditional marketing authorisation from the European Medicines Agency (EMA) to treat people with R/R DLBCL after two or more lines of systemic therapy. With this latest approval, the condition to convert the existing marketing authorisation to a regular approval has been fulfilled.
Background:
DLBCL is the most common subtype of non-Hodgkin lymphoma. Approximately one-third of patients with DLBCL experience a relapse or become refractory to initial treatment. These patients have limited treatment options and poor prognosis.
Impact on Patients:
This approval marks a significant milestone for patients with R/R DLBCL in Europe. The Columvi combination offers a new therapeutic option for these patients who have exhausted other treatment options. This approval also provides hope for those who are ineligible for autologous stem cell transplant (ASCT), a common treatment for R/R DLBCL.
Impact on the World:
The approval of Columvi in combination with GemOx for the treatment of R/R DLBCL in Europe is expected to have a profound impact on the lives of thousands of patients. According to the European Cancer Information System (ECIS), approximately 25,000 new cases of DLBCL are diagnosed in Europe each year. Around 8,000 of these patients are expected to relapse or become refractory to initial treatment.
The approval of Columvi is also expected to have a significant economic impact. According to a report by GlobalData, the DLBCL market in Europe is expected to grow from €1.7 billion in 2020 to €3.1 billion by 2025. The Columvi combination is expected to capture a significant share of this market.
Conclusion:
The European Commission’s approval of Columvi in combination with GemOx marks a significant milestone in the treatment of relapsed or refractory DLBCL in Europe. This approval offers a new therapeutic option for thousands of patients who have exhausted other treatment options and provides hope for those who are ineligible for autologous stem cell transplant. The impact of this approval is expected to be profound, not only for the lives of patients but also for the European healthcare system and the DLBCL market.
- Roche’s Columvi (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) has been approved by the European Commission for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified.
- This combination is the first bispecific antibody regimen available for people with DLBCL in Europe whose cancer has returned or for those who did not respond to initial treatment.
- The approval is expected to have a significant impact on the lives of thousands of patients in Europe and also on the European healthcare system and the DLBCL market.
