COLUMVI (Roche Products Pty Ltd)
Product name
COLUMVI
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
195 (255 working days)
Active ingredients
glofitamab
Registration type
NCE/NBE
Indication
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.
Registration process
Provisional registration
Involves early access to vital and life-saving medicines through time-limited registration
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.