Anvisa Registers Columvi for Relapsed Diffuse Large B‑Cell Lymphoma

Overview

• Anvisa registered Columvi, on Monday, July 20, 2026, authorizing its use in adults with relapsed or refractory diffuse large B‑cell lymphoma who are not eligible for autologous stem‑cell transplant.
• Columvi (glofitamab) is a bispecific antibody that links CD20 on B cells with CD3 on T cells to redirect the immune system and is prescribed with gemcitabine and oxaliplatin as a 12‑cycle outpatient IV treatment lasting about 8.3 months.
• Roche and reporting reference a global Lancet trial that showed large efficacy gains including a 41% reduction in risk of death, a 50.3% complete remission rate versus 22% for the comparator, and a 63% reduction in risk of progression.
• The therapy can trigger intense immune reactions such as cytokine release syndrome so clinics will need protocols for close monitoring and rapid management during administration.
• Commercial sale is now allowed but public‑system availability and private‑plan coverage must await Conitec and ANS reviews, a key issue for access given an estimated 4,000 annual DLBCL diagnoses in Brazil and the high cost and resource needs compared with CAR‑T and other options.