Minjuvi

Relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low-grade lymphoma, in combination with lenalidomide, in patients who are not eligible for autologous stem cell transplant (ASCT).

12 mg/kg IV
Cycle 1: Days 1, 4, 8, 15, 22
Cycles 2-3: Days 1, 8, 15
Cycle 4+: Days 1, 15
Each cycle is 28 days
With lenalidomide 25 mg daily Days 1-21 of each 28-day cycle for max 12 cycles
After 12 cycles with lenalidomide: continue tafasitamab monotherapy on Days 1, 15 of each 28-day cycle until progression
Infusion time: 1.5-2.5 hours depending on dose

Injection: 200 mg lyophilized powder in single-dose vial

None listed.

• Myelosuppression: Grade 3+ neutropenia (49%), thrombocytopenia (17%), anemia (7%). Monitor CBC before each treatment cycle.
• Infections: Serious infections in 26% (fatal in 3.6%). Including COVID-19, pneumonia, sepsis. Monitor for infections during and after treatment.
• Infusion-Related Reactions: In 6%. Pre-medicate with acetaminophen, antihistamine, and glucocorticoid for first 3 infusions.
• Embryo-Fetal Toxicity: Due to tafasitamab mechanism + lenalidomide combination.

Neutropenia (51%), fatigue (38%), anemia (36%), diarrhea (36%), thrombocytopenia (31%), cough (26%), pyrexia (24%), peripheral edema (24%), upper respiratory tract infection (22%), decreased appetite (22%), hypokalemia (19%), back pain (19%), rash (18%)

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

Consult the complete prescribing information for drug interactions, including effects on CYP enzymes, transporters, and concomitant medications that may require dose adjustments or monitoring.

Consult the full prescribing information for pregnancy-related considerations.

Refer to prescribing information for lactation guidance.

Pediatric safety and efficacy information is detailed in the full label.

Dose modifications for organ impairment are specified in the complete prescribing information.

Tafasitamab is a humanized anti-CD19 IgG1/2 hybrid monoclonal antibody with an Fc-engineered domain. The Fc modification (two amino acid substitutions: S239D and I332E) enhances binding to FcγRIIIa on natural killer cells and macrophages, resulting in enhanced antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP) against CD19-positive lymphoma cells. It also induces direct apoptosis of CD19-expressing B cells.

Half-life: approximately 17 days. Steady-state achieved by Cycle 4. Clearance: approximately 0.007 L/h. Volume of distribution: approximately 9.3 L. Minimal non-linearity.

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

• L-MIND — Tafasitamab + lenalidomide in relapsed/refractory DLBCL not eligible for ASCT. Phase II, n=81.
  🔬 NCT02399085 ↗ 📄 Primary Publication ↗

Minjuvi has FDA-approved indications across the following cancer types covered on PipelineEvidence: