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Common name: Tafasitamab-cxix
Trade name: Monjuvi
All names: tafasitamab-cxix, tafasitamab, Monjuvi
Indications:
MO NJUVI is a CD19-directed cytolytic antibody used in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL caused by low-grade lymphoma) who are not candidates for autologous stem cell transplantation (ASCT).
Usage and Dosage:
Before starting to take MONJUVI, you should first take prescription medication.
The recommended dose of MONJUVI is 12 mg/kg as an intravenous infusion according to the following dosing schedule:
Cycle 1: Days 1, 4, 8, 15, and 22 of a 28-day cycle.
Cycles 2 and 3: Days 1, 8, 15 and 22 of each 28-day cycle.
Cycle 4 and beyond: Days 1 and 15 of each 28-day cycle.
MONJUVI may be used in combination with lenalidomide for up to 12 cycles and then continued as monotherapy until disease progression or unacceptable toxicity.
Strengths:
Injection: 200 mg of tafasitamab-cxix lyophilized powder in single-dose vials for reconstitution.
Adverse Reactions:
The most common adverse reactions (≥20%) are neutropenia, fatigue, anemia, diarrhea, thrombocytopenia, cough, pyrexia, peripheral edema, respiratory tract infection and decreased appetite.
Contraindications:
None
Precautions:
Infusion-related reactions: Monitor the patient frequently during infusion. Interrupt or discontinue the infusion based on severity.
Myelosuppression: Monitor complete blood count. Manage with dose adjustment and growth factor support. Interrupt or abort MONJUVI based on severity.
Infections: Bacterial, fungal, and viral infections can occur during and after MONJUVI. Monitor patients for infections.
Embryo-fetal toxicity: May cause fetal harm. Women of reproductive potential are advised to use effective contraception which may result in potential risk to the fetus.
Storage:
Store refrigerated in original carton at 36°F to 46°F (2°C to 8°C), protected from light. Don't shake. Do not freeze.
Mechanism of action:
Tafasitamab-cxix is an Fc-modified monoclonal antibody that binds to the CD19 antigen expressed on the surface of pre-B lymphocytes and mature B lymphocytes, as well as on several B-cell malignancies, including diffuse large B-cell lymphoma.
After binding to CD19, tafasitamab-cxix mediates B cell lysis through apoptotic and immune effector mechanisms, including antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).
In in vitro studies in DLBCL tumor cells, tafasitamab-cxix combined with lenalidomide increased ADCC activity compared with tafasitamab-cxix or lenalidomide alone.
Safety and Efficacy:
Monjuvi is the first second-line therapy approved by the FDA for adult patients with r/r DLBCL whose disease has progressed during or after first-line treatment. Previously, the FDA had granted Monjuvi fast track qualifications, breakthrough drug qualifications, and priority review qualifications. Currently, Monjuvi is also under review by the European Medicines Agency (EMA).
This approval is based on data from the L-MIND study. This is an open-label, multicenter, single-arm Phase II study evaluating the combination of Monjuvi and lenalidomide in patients with r/r DLBCL who have received at least one but no more than three prior therapies (including an anti-CD20 targeted therapy, such as rituximab) and are ineligible for high-dose chemotherapy (HDC) and subsequent autologous stem cell transplantation (ASCT).
The results showed that the overall response rate (ORR) of Monjuvi + lenalidomide combination therapy was 55% (primary endpoint), the complete response rate (CR) was 37%, and the partial response rate (PR) was 18%. Responses were durable, with a median duration of response (mDOR) of 21.7 months (key secondary endpoint).