Roche has secured approval from the European Commission (EC) for Columvi (glofitamab) plus gemcitabine and oxaliplatin (GemOx) combo to treat adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL).
This authorisation permits the use of the combo for individuals not eligible for autologous stem cell transplant.
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The approval of the Columvi combo, the first bispecific antibody regimen for DLBCL in Europe, follows a conditional marketing authorisation granted in July 2023 for R/R DLBCL treatment.
The decision also satisfies the requirement to transition the present marketing authorisation to a standard approval.
The pivotal Phase III STARGLO trial outcomes underpin the EC approval, demonstrating that Columvi plus GemOx significantly improves overall survival compared to MabThera/Rituxan (rituximab) and GemOx (R-GemOx) in R/R DLBCL patients.
Columvi plus GemOx provides an off-the-shelf treatment regimen, providing a readily available option for infusion, which can help avoid delays in starting treatment.
Columvi and Lunsumio (mosunetuzumab) are a part of the company’s cluster of differentiation 20 (CD20)xCD3 bispecific antibody programme.
Roche Global Product Development head and chief medical officer Levi Garraway stated: “Columvi is the first treatment of its kind to improve survival outcomes for people with DLBCL whose cancer has returned after first-line therapy.
“With this approval, Columvi can now benefit patients even earlier in their treatment, adding to its existing value as an important treatment for DLBCL.”
Roche’s strategy encompasses the clinical development of allogeneic CAR T-therapies, aiming to offer tailored treatment alternatives for the diverse needs of individuals with blood cancers.
Columvi’s design involves a 2:1 structural format, targeting CD3 on T cells and CD20 on B cells.
The company continues to explore Columvi as both a single agent and with other medicines for the treatment of mantle cell lymphoma and DLBCL.
In the Phase III SKYGLO study, it is also being evaluated with Polivy (polatuzumab vedotin) and MabThera/Rituxan (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) for previously untreated DLBCL, to enhance long-term outcomes and relapse prevention.
In March 2025, Oxford BioTherapeutics (OBT) entered a multi-year partnership with Roche for antibody-based therapeutics to treat cancer.
