EC approves Roche’s Columvi for DLBCL

14 April 2025

The European Commission has approved 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 who are ineligible for autologous stem cell transplant (ASCT), Swiss pharma giant Roche (ROG: SIX) announced this morning.

According to Roche, with this broader label, the Columvi 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 authorization to treat people with R/R DLBCL after two or more lines of systemic therapy. In addition to today’s approval, a condition to convert the existing marketing authorization to a regular approval has been fulfilled, noted Roche, whose shares rose 3% to 251.10 francs by midday.

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