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Minjuvi
Published
Product name
Minjuvi
Active ingredient
Tafasitamab
Submission type
New Biological Entity
Decision
Approved for provisional registration.
Decision date
Registration date
What this medicine was approved for
Minjuvi (tafasitamab) was approved for the following therapeutic use:
The provisionally approved new indication(s) for the medicine(s) are:
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.
How this medicine works
Tafasitamab is an fragment crystallisable (Fc)-enhanced monoclonal antibody that targets the CD19 antigen expressed on the surface of pre-B and mature B lymphocytes. Upon binding to CD19, tafasitamab mediates B-cell lysis through:
- engagement of immune effector cells like natural killer cells, γδ T cells and phagocytes
- direct induction of cell death (apoptosis)
The Fc modification results in enhanced antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Minjuvi was considered favourable for the therapeutic use approved.