MINJUVI

What it is

MINJUVI is a 200 mg powder for solution for infusion containing tafasitamab. It is a powder for concentrate for solution for infusion presented as a white to slightly yellowish lyophilised powder. Tafasitamab is an 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 and direct induction of cell death (apoptosis).

Approved indications

— Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT), treated in combination with lenalidomide followed by MINJUVI monotherapy.

Dosing overview

The recommended dose of MINJUVI is 12 mg per kg body weight administered as an intravenous infusion on day 1, 4, 8, 15 and 22 of cycle 1; on day 1, 8, 15 and 22 of cycles 2 and 3; and on day 1 and 15 of each cycle from cycle 4 until disease progression, with each cycle having 28 days. Patients should self-administer lenalidomide capsules at the recommended starting dose of 25 mg daily on days 1 to 21 of each cycle. MINJUVI plus lenalidomide in combination is given for up to twelve cycles, after which treatment with lenalidomide should be stopped, and patients should continue to receive MINJUVI infusions as single agent on day 1 and 15 of each 28-day cycle, until disease progression or unacceptable toxicity.

Key safety warnings

Infusion-related reactions may occur and have been reported more frequently during the first infusion, and patients should be monitored closely throughout the infusion. Treatment with tafasitamab can cause serious and/or severe myelosuppression including neutropenia, thrombocytopenia, and anaemia, and complete blood counts should be monitored throughout treatment and prior to administration of each treatment cycle. Neutropenia, including febrile neutropenia, has been reported during treatment with tafasitamab, and administration of granulocyte colony-stimulating factors (G-CSF) should be considered, in particular in patients with Grade 3 or 4 neutropenia. Thrombocytopenia has been reported during treatment with tafasitamab, withholding of concomitant medicinal products that may increase bleeding risk should be considered, and patients should be advised to report signs or symptoms of bruising or bleeding immediately. Fatal and serious infections, including opportunistic infections, have occurred in patients during treatment with tafasitamab, and tafasitamab should be administered to patients with an active infection only if the infection is treated appropriately and well controlled. Progressive multifocal leukoencephalopathy (PML) has been reported during combination therapy with tafasitamab, patients should be monitored for new or worsening neurological symptoms or signs that may be suggestive of PML, and if PML is suspected, further dosing of tafasitamab must be immediately suspended. Patients with high tumour burden and rapidly proliferative tumour may be at increased risk of tumour lysis syndrome, tumour lysis syndrome has been observed in patients with DLBCL during treatment with tafasitamab, appropriate measures/prophylaxis should be taken prior to treatment, and patients should be monitored closely for tumour lysis syndrome during treatment.

Contraindications

Hypersensitivity to the active substance or to any of the excipients.

PBS listing

No information regarding PBS listing is provided in the source documents.

Regulatory history

MINJUVI was first listed on the Australian Register of Therapeutic Goods on 20 June 2023. MINJUVI was approved for provisional registration on 19 June 2023. This indication was approved via the provisional approval pathway, based on objective response rate and duration of response in a single arm trial, and continued approval for this indication depends on verification and description of clinical benefit in a confirmatory trial. This medicinal product is subject to additional monitoring in Australia due to provisional approval, which will allow quick identification of new safety information.