Key Points

Studies have shown an overall response rate of 55% in adults (39 of 71) with advanced diffuse large B-cell lymphoma (DLBCL) who received Monjuvi (tafasitamab-cxix) treatment (plus lenalidomide) for up to 12 (28 day) cycles. Patients receiving Monjuvi in combination with rituximab and lenalidomide for relapsed or refractory follicular lymphoma (FL) achieved a median progression-free survival (PFS) of 22.4 months (95% CI, 19.2-not evaluable [NE]) compared to 13.9 months (95% CI, 11.5-16.4) in the placebo control arm.

Monjuvi is a targeted immunotherapy treatment that works by binding to CD19 markers found on the surface of B lymphocytes (a type of white blood cell). Monjuvi belongs to the drug class called CD19-directed cytolytic antibodies.

Monjuvi is given as an intravenous (IV) infusion by a healthcare provider, 2 to 5 times during a 28-day cycle, depending upon your medication condition.

L-MIND Trials

Diffuse large B-cell lymphoma (DLBCL)

The L-MIND pivitol trial was an open-label, multicenter, single-arm, and Phase 2 study.

In this study, Monjuvi (tafasitamab-cxix) plus Revimid (lenalidomide) was studied in 71 people whose DLBCL returned, worsened, or did not respond to 1 to 3 previous treatments and who could also not receive a stem cell transplant. They received this combined treatment for up to 12 cycles (about a year), then they were given Monjuvi alone.

• Monjuvi combined with oral lenalidomide led to a partial or complete response (overall response rate) in 55% of patients (39 of 71). (95% CI 43%, 67%)
• In trials, 37% of patients reached a complete response (remission). Complete response means all signs of cancer have disappeared in response to treatment, but does not always mean the cancer has been cured.
• Also, 18% of people had partial response. Partial response is a decrease in the size of a tumor (usually by one-half in DLBCL), or in the extent of cancer in the body, in response to treatment.
• The median duration of response was 21.7 months. The median duration of response is the amount of time that 50% of the people continued to stay in remission at the time the study analysis was done. Remission is a temporary or permanent reduction or dissappearance of disease symptoms
• The median time to response was 2 months, but was an exploratory outcome.

What is DLBCL?

Diffuse large B-cell lymphoma (DLBCL), a blood cancer, is the most common type of non-Hodgkin lymphoma in adults. It is characterized by aggressive growth of cancerous B-cells in the lymph nodes, spleen, liver, bone marrow or other organs. About 1 in 3 patients do not respond to initial therapy or relapse, and require additional treatment options.

This use is approved by the FDA under an accelerated approval based on overall response rate (an intermediate clinical endpoint). Continued approval of Monjuvi for DLBCL may depend upon results from additional clinical studies.

L-MIND 5-Year Data: DLBCL

In clinical studies looking at results after 5 years of treatment, Monjuvi maintained a partial or complete response (ORR) in 54% of patients with advanced diffuse large B-cell lymphoma (DLBCL), similar to what was seen in the one-year study.

5-year follow-up with Monjuvi

• 54% overall response rate
• 37% complete response rate
• 17% partial response rate

Approximately 57% of patients who had responded to treatment were still in remission at 5 years. With a median follow-up of 54 months (about 4.5 years), the median duration of response was not reached, demonstrating a sustained response.

Note: The 5-year follow-up data should be interpreted with caution. The 5-year analysis from L-MIND have not been reviewed by the FDA, and potential inclusion of these data in the final FDA-approved labeling has yet to be determined.

Discuss long-term use of Monjuvi with your health care provider. Your healthcare team is always the best place to get your cancer treatment information.

Phase 3 inMIND Trial: FL

Approval for Monjuvi in relapsed or refractory follicular lymphoma (FL) was based on the Phase 3, randomized, double blind, placebo-controlled inMIND trial evaluating the efficacy and safety of Monjuvi in 548 adults with relapsed or refractory FL. Monjuvi or placebo was used in combination with rituximab and oral lenalidomide. Treatment was continued for up to twelve 28-day cycles.

The primary endpoint of progression-free survival (PFS) was met. Patients receiving Monjuvi in combination with rituximab and lenalidomide achieved a median PFS of 22.4 months (95% CI, 19.2-not evaluable [NE]) compared to 13.9 months (95% CI, 11.5-16.4) in the control arm (hazard ratio [HR]: 0.43 [95% CI, 0.32-0.58]; P<0.0001). The median duration of PFS follow-up was 14.1 months.

Results showed 27.5% of patients with an event in the Monjuvi group vs. 47.6% of patients with an event in the control arm. Disease progression was seen in 24% of those in the Monjuvi arm vs. 45.1% in the placebo group, and death in 2.9% vs. 2.5%, respectively.

The overall response rate (complete response plus partial response) was 84% in the Monjuvi group vs. 72% in the placebo control arm.

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How do I receive Monjuvi?

Monjuvi is given as an infusion into your vein (intravenous infusion), which may take up to 2.5 hours to complete. A healthcare provider will give you this injection, usually at a clinic or local infusion center. It is used in combination with other medicines known as lenalidomide, or lenalidomide plus rituximab, depending upon your medical condition.

You may receive other medicines before your infusion to help decrease your chance for a side effect like chills, fever, flushing, shortness of breath or headache. Keep using these medicines for as long as your doctor has prescribed. If you tolerate the infusion well, your doctor may decide to discontinue these extra medicines with later infusions.

If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.

How many days are in the Monjuvi treatment cycle?

Monjuvi is given in a 28-day treatment cycle. A cycle is a period of medication treatment followed by a period of rest. You will receive medication on certain days of each 28-day cycle.

Monjuvi is given along with oral lenalidomide, another type of medicine that slows lymphoma cancer growth, blocks new blood vessel growth in tumors, and enables the immune system to fight cancer.

Diffuse large B-cell lymphoma (DLBCL)

The normal treatment cycle for Monjuvi for DLBCL is as follows:

• You will receive Monjuvi on days 1, 4, 8, 15, and 22 during your first cycle (first 28 days).
• You will receive Monjuvi on days 1, 8, 15, and 22 during your second and third cycles (usually the 2nd and 3rd month).
• After your first 3 cycles, you will receive Monjuvi once every 2 weeks, on days 1 and 15.

Your healthcare provider will prescribe a 25 mg lenalidomide capsule for you to take on days 1 to 21 of each 28-day treatment cycle, for the first 12 cycles (the first year). Lenalidomide is taken as a capsule by mouth once daily.

After 12 cycles (usually about one year), you will receive only Monjuvi as maintenance therapy on days 1 and 15 of each cycle (each 28-day period). You will no longer take lenalidomide.

For DLBCL, Monjuvi treatment is then normally continued until you have side effects you cannot tolerate or your disease progresses.

Follicular Lymphoma (FL)

Your healthcare provider may need to delay or discontinue your treatment if you have severe side effects.

Possible side effects

The most common side effects you may have with Monjuvi treatment include

• Feeling tired or weak
• Diarrhea
• Constipation
• Cough
• Rash
• Fever
• Swelling of lower legs or hands
• Respiratory tract infection
• Decreased appetite
• Lowered red and white blood cell counts
• Lowered platelets
• Muscle or bone pain

More serious side effects are: infusion reactions, low blood cells counts (platelets, red blood cells, and white blood cells) and infections.

• Related: Review Monjuvi warnings, precautions and side effects (in more detail)

This is not all the information you need to know about Monjuvi (tafasitamab-cxix) for safe and effective use and does not take the place of your doctor’s directions. Review the full product information and discuss this information and any questions you have with your doctor or other health care provider.

References

• Monjuvi [prescribing information]. 6/2025. Wilmington, DE. Incyte Corp. Accessed June 2025 at https://www.monjuvi.com/pi/monjuvi-pi.pdf
• Salles G, Duell J, González Barca E, et al. Tafasitamab plus lenalidomide in relapsed or refractory diffuse large B-cell lymphoma (L-MIND): a multicentre, prospective, single-arm, phase 2 study. Lancet Oncol. 2020 Jul;21(7):978-988. doi: 10.1016/S1470-2045(20)30225-4. 
• FDA Approves Monjuvi (tafasitamab-cxix) in Combination with Lenalidomide for the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL). July 31, 2020. Drugs.com. Accessed July 31, 2024 at https://www.drugs.com/newdrugs/fda-approves-monjuvi-tafasitamab-cxix-combination-lenalidomide-relapsed-refractory-diffuse-large-b-5312.html
• NCI Dictionary of Cancer Terms. National Cancer Institute (NCI). Accessed July 31, 2024 at https://www.cancer.gov/publications/dictionaries/cancer-terms/
• Monjuvi.com. FAQs. Accessed July 31, 2024 at https://www.monjuvi.com/faqs
• 5 Year Analysis: Efficacy. Monjuvi.com. Accessed Aug 30, 2024 at https://www.monjuvihcp.com/long-term-analysis
• Duell J, Abrisqueta P, Andre M, et al. Tafasitamab for patients with relapsed or refractory diffuse large B-cell lymphoma: final 5-year efficacy and safety findings in the phase II L-MIND study. Haematologica. 2024 Feb 1;109(2):553-566. doi: 10.3324/haematol.2023.283480
• Incyte Announces FDA Approval of Monjuvi (tafasitamab-cxix) in Combination with Rituximab and Lenalidomide for Patients with Relapsed or Refractory Follicular Lymphoma. June 18, 2025. Drugs.com https://www.drugs.com/newdrugs/incyte-announces-fda-approval-monjuvi-tafasitamab-cxix-combination-rituximab-lenalidomide-patients-6554.html

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