Roche announced that the EU’s European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Columvi® (glofitamab) for the treatment of adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) as a third line therapy. The recommendation was based on results from a phase I/II study, in which Columvi® was demonstrated to induce early and long-lasting responses in people with R/R DLBCL.
This news comes less than two weeks since the FDA approved Genentech/Roche’s Polivy® (polatuzumab vedotin-piiq) in combination with Rituxan® (rituximab) for DLBCL.