Roche’s Columvi approved as the first bispecific antibody for diffuse large B-cell lymphoma after initial therapy

Roche announces that the European Commission has approved Columvi in combination with gemcitabine and oxaliplatin (GemOx) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified who are ineligible for autologous stem cell transplant. 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.

“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.”

“People with R/R DLBCL not eligible for ASCT represent a challenging population, especially those with primary refractory disease or early relapse whose need for a readily accessible and effective therapy is insufficiently addressed globally,” said Franck Morschhauser, MD, PhD, Professor of Haematology, University Hospital Lille and STARGLO study investigator. “This new Columvi combination is immediately available if a patient’s cancer returns or doesn’t respond to first-line therapy, which is a welcome addition to manage DLBCL.”

Note that DLBCL is an aggressive type of lymphoma and is one of the most prevalent types of blood cancer among adults. In Europe, an estimated 38,000 people are diagnosed with DLBCL each year. 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.

Nonetheless the second-line treatment advances have been made, challenges with the accessibility of existing medicines and the aggressive nature of DLBCL underscores the urgent need for immediately available treatment options that can control the disease and improve survival. Columvi in combination with GemOx offers an ‘’off-the-shelf’’ treatment regimen, readily available for infusion in any setting, meaning patients can avoid delays in starting their next treatment. Columvi is also designed to be given for a fixed period offering a target end date for people’s course of therapy and the possibility of a treatment-free period after completion.

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Related Topics and Keywords

large b cell lymphoma, Roche’s