CHMP recommends EU approval of Roche’s Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma

Basel, 28 February 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Columvi® (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified who are ineligible for autologous stem cell transplant (ASCT). The standard second-line (2L) therapy for R/R DLBCL patients has historically been high-dose chemotherapy followed by stem cell transplant. New therapies have been recently introduced, however, not all patients can access or are eligible for these treatments.³ If approved, this Columvi combination could provide a much-needed, off-the-shelf treatment option. A final decision is expected from the European Commission in the near future.