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COLUMVI (Roche Products Pty Ltd)
Product name
COLUMVI
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
192 (255 working days)
Active ingredients
glofitamab
Registration type
EOI
Indication
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