Roche announces EC has approved Columvi to treat large B-cell lymphoma

Roche (RHHBY) announced that the European Commission, EC, has approved Columvi in combination with gemcitabine and oxaliplatin for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified who are ineligible for autologous stem cell transplant, ASCT. With this approval, this 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 authorisation 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 authorisation to a regular approval has been fulfilled. “Columvi is the first treatment of its kind to improve survival outcomes for people with DLBCL whose cancer has returned after first-line therapy,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “With this approval, Columvi can now benefit patients even earlier in their treatment, adding to its existing value as an important treatment for DLBCL.”