Tafasitamab

Pronunciation: TA-fa-SIT-a-mab
Generic name: tafasitamab-cxix
Brand name: Monjuvi
Dosage form: powder for intravenous infusion (200 mg)
Drug class: CD19 monoclonal antibodies

Medically reviewed by Carmen Pope, BPharm. Last updated on July 7, 2025.

What is tafasitamab?

Tafasitamab (Monjuvi) is used in combination with lenalidomide to treat certain types of relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL), or in combination with lenalidomide and rituximab for r/r follicular lymphoma (FL). It is given as an intravenous infusion by a healthcare provider, 2 to 5 times during a 28-day cycle.

Tafasitamab works by binding to CD19 markers expressed on the surface of B-cell cancers, such as DLBCL and FL. Once bound, tafasitamab signals the immune system to attack and destroy these cells. Tafasitamab is a targeted immunotherapy treatment and belongs to the drug class called CD19-directed cytolytic antibodies. It is only available under the brand name Monjuvi.

FDA approvals and uses

Tafasitamab is approved in combination with:

• lenalidomide for relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from low-grade lymphoma, in adults who are not eligible for autologous stem cell transplant (ASCT)
  • This approval is under the accelerated approval designation, and continued approval may be contingent upon a continued clinical benefit being shown in confirmatory trials.
• lenalidomide and rituximab for r/r follicular lymphoma (FL).

Tafasitamab is not recommended for relapsed or refractory marginal zone lymphoma outside of controlled clinical trials.

It is not known if tafasitamab is safe and effective in children.

Tafasitamab gained FDA approval on July 31, 2020, for r/r DLBCL in combination with lenalidomide, based on positive results from the open-label Phase 2 L-MIND clinical trial (NCT02399085), which reported:

• 55% of people treated with tafasitamab reached remission at 1 year
• 37% had a complete remission
• 18% had a partial remission.

Approval was extended on June 18, 2025, to include r/r FL in combination with lenalidomide and rituximab based on positive results from the Phase 3 inMIND clinical trial (NCT04680052), which reported tafasitamab extended progression-free survival (PFS) to 22.4 months compared to 13.9 months in those not assigned it. 

Side effects

The most common side effects of tafasitamab when given with lenalidomide in DLBCL are:

• respiratory tract infection
• feeling tired or weak
• diarrhea
• cough
• fever
• swelling of the lower legs or hands
• decreased appetite
• infusion-related reactions.

The most common side effects of tafasitamab when given with lenalidomide and rituximab in FL are:

• respiratory tract infections
• diarrhea
• rash
• feeling tired or weak
• muscle and bone pain
• constipation
• cough
• infusion-related reactions.

Warnings and serious side effects 

Tafasitamab may cause the following serious side effects:

• Infusion reactions. Your healthcare provider will monitor you for infusion reactions during your infusion of tafasitamab. Tell your healthcare provider right away if you get a fever, chills, rash, flushing, headache, or shortness of breath during an infusion of tafasitamab.

• Low blood cell counts (platelets, red blood cells, and white blood cells). Low blood cell counts are common with tafasitamab, but can also be serious or severe. Your healthcare provider will monitor your blood counts during treatment with tafasitamab. Tell your healthcare provider right away if you get a fever of 100.4°F (38°C) or above, or any bruising or bleeding, fever, mouth sores, skin sores, sore throat, cough, or trouble breathing.

• Infections. Serious infections, including infections that can cause death, have happened in people during treatment with tafasitamab and after the last dose. Tell your healthcare provider right away if you get a fever of 100.4°F (38°C) or above, or develop any signs or symptoms of an infection, such as:
  • cough with mucus, chest tightness, shortness of breath
  • fever above 100.4 degrees F (38 degrees C)
  • pain or burning when you urinate.

As with any medication, allergic reactions may happen. Get emergency medical help if you have signs of an allergic reaction to tafasitamab: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Tafasitamab may harm an unborn baby. Use effective birth control to prevent pregnancy while using tafasitamab and for at least 3 months after your last dose. Carefully follow all instructions about the use of birth control while you are using tafasitamab in combination with lenalidomide.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Related/similar drugs

Before taking

Before you receive tafasitamab, tell your healthcare provider about all of your medical conditions, including if you:

• have an active infection or have had one recently
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Pregnancy

Tafasitamab may harm your unborn baby. You should not become pregnant during treatment with tafasitamab. 

Tafasitamab is used 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. Both men and women using lenalidomide must use effective birth control. Even one dose can cause severe, life-threatening birth defects or death of a baby if the mother or the father is taking lenalidomide at the time of conception or during pregnancy. You should also read the lenalidomide Medication Guide for important information about pregnancy, contraception, blood, and sperm donation.

• Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with tafasitamab.

Breastfeeding

 It is not known if tafasitamab passes into your breastmilk. Do not breastfeed during treatment and for at least 3 months after your last dose of tafasitamab.

How is tafasitamab given?

Tafasitamab will be given to you by your healthcare provider as an intravenous (IV) infusion into one of your veins.

• Your healthcare provider will administer premedications 30 minutes to 2 hours before starting the infusion to minimize infusion-related reactions.
• Premedications may include acetaminophen, histamine H1 receptor antagonists, histamine H2 receptor antagonists, and/or glucocorticosteroids.
• For patients not experiencing infusion-related reactions during the first 3 infusions, premedication is optional for subsequent infusions.
• This medicine must be given slowly, and the infusion can take up to 2.5 hours to complete.

Each treatment cycle of tafasitamab lasts for 28 days.

• Tafasitamab will be given 2 to 5 times during the 28-day cycle, depending on the type of cancer you have or how many weeks through your treatment you are.
• Your healthcare provider will decide how many treatments you need.
• Your healthcare provider may need to delay or completely stop treatment with tafasitamab if you have severe side effects.
• If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.
• Tafasitamab affects your immune system. You may get infections more easily, even serious or fatal infections. Your doctor will need to examine you regularly.

Dosing information

Dose of tafasitamab for r/r DLBCL in combination with lenalidomide (Adults)

• 12 mg/kg as an IV infusion according to the following dosing schedule:
  • 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 the 28-day cycle.
  • Cycle 4 and beyond: Days 1 and 15 of each 28-day cycle.

Administer tafasitamab in combination with lenalidomide for a maximum of 12 cycles and then continue tafasitamab as monotherapy until disease progression or unacceptable toxicity occurs.

Dose of tafasitamab for r/r FL in combination with lenalidomide and rituximab (Adults)

• 12 mg/kg as an IV infusion according to the following dosing schedule:
  • 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 tafasitamab in combination with lenalidomide (Cycles 1 to 12) and rituximab (Cycles 1 to 5). 

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your tafasitamab injection.

What other drugs will affect this medicine?

Other drugs may interact with tafasitamab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. 

Ingredients

Active ingredient: tafasitamab-cxix.

Inactive ingredients (Monjuvi): citric acid monohydrate, polysorbate 20, sodium citrate dihydrate, and trehalose dihydrate.

Tafasitamab is supplied as 200 mg of tafasitamab-cxix as lyophilized powder in a single-dose vial for reconstitution.

Company

Tafasitamab is manufactured by the Incyte Corporation, under the brand name Monjuvi. Incyte is located in Wilmington, DE 19803.

Tafasitamab Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for tafasitamab.

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Further information

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