Columvi 2.5 mg/2.5 ml, concentrate for solution for infusion

( ARTG ) COLUMVI monotherapy with obinutuzumab pretreatment has provisional approval for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. COLUMVI is not indicated for the treatment of patients with primary central nervous system lymphoma. The decision to approve this indication has been made on the basis of Complete Response and the Overall Response Rate from an uncontrolled, open label phase I/II study. Continued approval of this indication depends on verification and description of benefit in confirmatory trials.COLUMVI in combination with gemcitabine and oxaliplatin with obinutuzumab pretreatment is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified (DLBCL NOS) who are not candidates for autologous stem cell transplant (ASCT). COLUMVI is not indicated for the treatment of patients with primary central nervous system lymphoma.