Roche's fixed-duration Columvi approved by EC

Adding to US regulatory approval last month for its dual action antibody, Swiss pharma giant Roche (ROG: SIX) today announced that the European Commission (EC) has granted conditional marketing authorization 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.

Roche noted that 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, according to Roche.