European Commission grants conditional marketing authorisation to Roches Columvi to treat r/r diffuse large B-cell lymphoma

Roche announced that the European Commission (EC) has granted conditional marketing authorisation for Columvi (glofitamab) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. With this approval, Columvi is the first CD20xCD3 T-cell-engaging bispecific antibody available to treat people in Europe with the most common and aggressive form of lymphoma following multiple lines of therapy. Columvi has the potential to change the current standard of care in DLBCL. As well as inducing early and long-lasting responses in people with heavily pre-treated or refractory DLBCL, Columvi is designed to be given for a fixed period of time meaning that people have a target end date for their course of treatment and the possibility of a treatment-free period. It is also a chemotherapy-free treatment option that is off-the-shelf, meaning that people do not have to wait for cell collection and genetic engineering - a multistep process that can take several weeks - before starting treatment. This could be particularly important for patients who are at a high-risk of their disease progressing. DLBCL is an aggressive (fast-growing) type of lymphoma and is one of the most prevalent types of blood cancer among adults. Each year in Europe, an estimated 36,000 people are diagnosed with DLBCL. While many patients with DLBCL are responsive to initial treatment, four out of ten are not cured with the current standard of care, frontline treatment, and the majority of patients who require subsequent lines of therapy have poor outcomes.

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