MINJUVI (Specialised Therapeutics Alim Pty Ltd)
Product name
MINJUVI
Date registered
Evaluation commenced
Decision date
Approval time
183 (255 working days)
Active ingredients
tafasitamab
Registration type
NCE/NBE
Indication
MINJUVI is indicated in combination with lenalidomide followed by MINJUVI monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).,This indication was approved via the provisional approval pathway, based on objective response rate and duration of response in a single arm trial. Continued approval for this indication depends on verification and description of clinical benefit in a confirmatory trial.
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.