Tafasitamab

Tafasitamab-cxix is an Fc-modified monoclonal antibody that binds to CD19 antigen expressed on the surface of pre-B and mature B lymphocytes and on several B-cell malignancies, including diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL). Upon binding to CD19, tafasitamab-cxix mediates B-cell lysis through apoptosis and immune effector mechanisms, including antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).

• MONJUVI is a CD19-directed cytolytic antibody indicated: 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 arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate.ICD-10: C85.90

• None. None.contraindicated

Administer premedications prior to starting MONJUVI. ( 2.4 ) See Full Prescribing Information for instructions on preparation and administration. ( 2.6 ) Diffuse Large B-cell Lymphoma The recommended dosage of MONJUVI is 12 mg/kg as an intravenous infusion according to the following dosing schedule: ( 2.2 ) Cycle 1: Days 1, 4, 8, 15, and 22 of the 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. Administer MONJUVI in combination with lenalidomide for a maximum of 12 cycles and then continue MONJUVI as monotherapy until disease progression or unacceptable toxicity. ( 2.2 ) Follicular Lymphoma The recommended dosage of MONJUVI is 12 mg/kg as an intravenous infusion according to the following dosing schedule: ( 2.3 ) Cycles 1 to 3: Days 1, 8, 15, and 22 of each 28-day cycle. Cycles 4 to 12: Days 1 and 15 of each 28-day cycle. Administer MONJUVI in combination with lenalidomide (Cycles 1 to 12) and rituximab (Cycles 1 to 5). ( 2.3 ) 2.1 Important Dosing Information MONJUVI should be administered by a healthcare professional with immediate access to emergency equipment and appropriate medical support to manage infusion-related reactions [see Warnings and Precautions ( 5.1 )]. 2.2 Recommended Dosage for Relapsed or Refractory Diffuse Large B‑cell Lymphoma The recommended dose of MONJUVI is 12 mg/kg based on actual body weight administered as an intravenous infusion in combination with lenalidomide, according to the dosing schedule in Table 1.

Infusion-Related Reactions : Monitor patients frequently during infusion. Interrupt or discontinue infusion based on severity. ( 2.5 , 5.1 ) Myelosuppression : Monitor complete blood counts. Manage using dose modifications and growth factor support. Interrupt or discontinue MONJUVI based on severity. ( 2.5 , 5.2 ) Infections : Bacterial, fungal and viral infections can occur during and following MONJUVI. Monitor patients for infections. ( 2.5 , 5.3 ) Embryo-Fetal Toxicity : May cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and use of effective contraception. ( 5.4 ) 5.1 Infusion-Related Reactions MONJUVI can cause infusion-related reactions [see Adverse Reactions ( 6.1 )] . In L-MIND, infusion-related reactions occurred in 6% of the 81 patients with DLBCL who received MONJUVI. Eighty percent of infusion-related reactions occurred during cycle 1 or 2. In inMIND, infusion-related reactions occurred in 16% of the 274 patients with FL who received MONJUVI in combination with lenalidomide and rituximab. Signs and symptoms included fever, chills, rash, flushing, dyspnea, and hypertension. These reactions were generally managed with temporary interruption of the infusion and/or with supportive medication. Premedicate patients prior to starting MONJUVI infusion [see Dosage and Administration ( 2.4 )] . Monitor patients frequently during infusion. Based on the severity of the infusion-related reaction, interrupt or discontinue MONJUVI [ see Dosage and Administration ( 2.5 )] . Institute appropriate medical management.

The following clinically significant adverse reactions are described elsewhere in the labeling: Infusion-related reactions [see Warnings and Precautions ( 5.1 )] Myelosuppression [see Warnings and Precautions ( 5.2 )] Infections [see Warnings and Precautions ( 5.3 )] The most common adverse reactions (≥ 20%) in patients with relapsed or refractory DLBCL are neutropenia, respiratory tract infection, fatigue, anemia, diarrhea, thrombocytopenia, cough, pyrexia, peripheral edema, and decreased appetite. ( 6.1 ) The most common adverse reactions (≥ 20%), excluding laboratory abnormalities, in patients with relapsed or refractory FL are respiratory tract infections, diarrhea, rash, fatigue, constipation, musculoskeletal pain, and cough. The most common Grade 3 or 4 laboratory abnormalities (≥ 20%) are decreased neutrophils and decreased lymphocytes. To report SUSPECTED ADVERSE REACTIONS, contact Incyte Corporation at 1-855-463-3463 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in other clinical trials of another drug and may not reflect the rates observed in practice. Relapsed or Refractory Diffuse Large B-cell Lymphoma The safety of MONJUVI in patients with relapsed or refractory DLBCL was evaluated in L-MIND [see Clinical Studies ( 14 .1 )].

Lactation : Advise not to breastfeed. ( 8.2 ) 8.1 Pregnancy Risk Summary Based on its mechanism of action, MONJUVI may cause fetal B-cell depletion when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] . There are no available data on MONJUVI use in pregnant women to evaluate for a drug-associated risk. Animal reproductive toxicity studies have not been conducted with tafasitamab-cxix. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. MONJUVI is administered in combination with lenalidomide, as well as in combination with lenalidomide and rituximab for up to 12 cycles. Lenalidomide can cause embryo-fetal harm and is contraindicated for use in pregnancy. Refer to the lenalidomide prescribing information for additional information. Lenalidomide is only available through a REMS program. Clinical Considerations Fetal/Neonatal Adverse Reactions Immunoglobulin G (IgG) monoclonal antibodies are transferred across the placenta. Based on its mechanism of action, MONJUVI may cause depletion of fetal CD19 positive immune cells. Defer administering live vaccines to neonates and infants exposed to tafasitamab-cxix in utero until a hematology evaluation is completed.

Metabolism

Pharmacokinetic (PK) parameters are presented as geometric mean (CV%) unless otherwise specified. Tafasitamab-cxix maximum concentration is achieved at the end of weekly dosing (i.e., end of Cycle 3).

• Jul 31, 2020BLABLA761163Morphosys Us Inc

1. 1Disease Progression23026%
2. 2Off Label Use16319%
3. 3Lymphoma15818%
4. 4Death627.1%
5. 5Drug Ineffective455.2%
6. 6Neutropenia374.3%
7. 7Diffuse Large B-cell Lymphoma364.1%
8. 8Blood Lactate Dehydrogenase Increased343.9%
9. 9Malignant Neoplasm Progression333.8%
10. 10Covid-19303.5%
11. 11Polyneuropathy293.3%
12. 12Diarrhoea283.2%
13. 13Cytopenia252.9%
14. 14Pyrexia252.9%
15. 15Fatigue242.8%

The 10 most recently updated of 61 ClinicalTrials.gov registrations naming Tafasitamab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Study of Tafasitamab and Lenalinomide Associated to Rituximab in Frontline Diffuse Large B-Cell Lymphoma Patients of 80 y/o or Older
  Active not recruiting · Phase 2 · Interventional · 71 enrolled · The Lymphoma Academic Research Organisation
  NCT04974216updated 2026-06-04
• Efficacy and Safety of Sequential Autologous Hematopoietic Stem Cell Transplantation Combined With Tafasitamab, Lenalidomide, and Standard Immunochemotherapy for Relapsed/Refractory Diffuse Large B-cell Lymphoma
  Active not recruiting · Phase 2 · Interventional · 25 enrolled · The First Affiliated Hospital of Soochow University
  NCT07621406updated 2026-06-02
• Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders
  Recruiting · Phase 2 · Interventional · 56 enrolled · Incyte Corporation
  NCT07104565updated 2026-06-01
• A Phase II Trial of Mosunetuzumab, Polatuzumab, Tafasitamab, and Lenalidomide in Patients With Relapsed B-cell NHL
  Recruiting · Phase 2 · Interventional · 36 enrolled · M.D. Anderson Cancer Center
  NCT05615636updated 2026-05-20
• To Assess the Safety and Tolerability of Tafasitamab Alone or in Combination With Other Drugs in Japanese Participants With Non-Hodgkins Lymphoma (NHL)
  Active not recruiting · Phase 1 · Phase 2 · Interventional · 72 enrolled · Incyte Biosciences Japan GK
  NCT04661007updated 2026-05-18
• A Exploratory Study on Untreated Follicular Lymphoma With Orelabrutinib, Tafasitamab, and Lenalidomide
  Not yet recruiting · Phase 2 · Interventional · 27 enrolled · Institute of Hematology & Blood Diseases Hospital, China
  NCT07585747updated 2026-05-14
• Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
  Not yet recruiting · Phase 2 · Interventional · 35 enrolled · City of Hope Medical Center
  NCT07582159updated 2026-05-12
• Phase I Master Protocol of Novel Combination Therapy for Patients With Relapsed or Refractory Aggressive B-Cell Lymphoma
  Active not recruiting · Early phase 1 · Interventional · 40 enrolled · Canadian Cancer Trials Group
  NCT04161248updated 2026-05-12
• Chemotherapy (DA-EPOCH+/-R) and Targeted Therapy (Tafasitamab) for the Treatment of Newly-Diagnosed Philadelphia Chromosome Negative B Acute Lymphoblastic Leukemia
  Active not recruiting · Phase 2 · Interventional · 32 enrolled · University of Washington
  NCT05453500updated 2026-05-11
• Tafasitamab and Zanubrutinib for the Treatment of Patients With Newly Diagnosed Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, TaZA CLL Study
  Active not recruiting · Phase 2 · Interventional · 26 enrolled · City of Hope Medical Center
  NCT05718869updated 2026-05-08

Frequently asked questions

How does Tafasitamab work?

Tafasitamab-cxix is an Fc-modified monoclonal antibody that binds to CD19 antigen expressed on the surface of pre-B and mature B lymphocytes and on several B-cell malignancies, including diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL). Upon binding to CD19, tafasitamab-cxix mediates B-cell lysis through apoptosis and immune effector mechanisms, including antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).

What is Tafasitamab used for?

According to FDA labeling, Tafasitamab carries indications including: MONJUVI is a CD19-directed cytolytic antibody indicated: 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 arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Tafasitamab?

Tafasitamab is classified as Other monoclonal antibodies and antibody drug conjugates, CD19-directed Antibody Interactions, Unknown Physiological Effect.

What are the brand names for Tafasitamab?

Tafasitamab is marketed under brand names including Monjuvi.

What are the contraindications for Tafasitamab?

Tafasitamab labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.