Columvi® is the official global commercial brand name, and Gaoluohua is its Chinese brand name developed by Roche. It is a bispecific CD3/CD20 monoclonal antibody for intravenous infusion. It crosslinks CD3-expressing T cells and CD20-positive malignant B cells, activating endogenous T cells to eliminate lymphoma cells.
Main Indications
Monotherapy for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have received at least two prior lines of systemic therapy;
Combined with gemcitabine and oxaliplatin for adult patients with relapsed/refractory DLBCL ineligible for autologous hematopoietic stem cell transplantation.
Clinical Research
Global multicenter phase II NP30179 pivotal trials fully validated its durable complete remission rate for multi-line pretreated refractory DLBCL;
Head-to-head external control comparative trials confirmed superior long-term survival benefit versus conventional salvage chemotherapy regimens;
Long-term follow-up extension cohorts demonstrated sustained deep remission in responders after fixed-duration induction treatment;
Dose-escalation research verified balanced anti-tumor efficacy and cytokine release syndrome management safety of the 10mg core maintenance dose;
Chinese domestic registration trials confirmed consistent therapeutic activity and manageable adverse reaction spectrum for domestic R/R DLBCL populations.
Common Side Effects
Common mild adverse reactions: Cytokine release syndrome (CRS), musculoskeletal pain, rash, fatigue and fever;
Laboratory abnormalities: Transient neutropenia, lymphopenia, thrombocytopenia and elevated liver transaminases;
Severe but uncommon risks: Severe grade 3–4 CRS, immune effector cell-associated neurotoxicity syndrome (ICANS), severe prolonged cytopenia and severe infectious complications.
Approval Status in China
Original drug Columvi® (Chinese brand: Gaoluohua) was first approved for marketing in China in November 2023, with the specification of 10 mg (10 mL) per vial, 1 vial per box. It is currently a prescription bispecific anti-lymphoma drug included in China’s Category B medical insurance catalogue.
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