There are two types of lymphomas: Hodgkin's and non-Hodgkin's, based on the kind of white blood cell they affect. Follicular lymphoma is a non-Hodgkin's lymphoma that affects white blood cells called lymphocytes. Follicular lymphoma mostly affects a specific type of lymphocyte called a B cell. B cells normally help protect your body by fighting off germs. But people with follicular lymphoma have B cells that become cancerous.
On June 18, 2025, Monjuvi (tafasitamab-cxix) was approved by the FDA for adults with follicular lymphoma that came back or did not get better after previous treatment. Monjuvi is usually used along with two other medicines, rituximab and lenalidomide.
Monjuvi is also FDA-approved for another cancer called diffuse large B-cell lymphoma (DLBCL). Monjuvi may also be used for other conditions as determined by your health care provider. This article focuses on Monjuvi for treating follicular lymphoma.
How Does Monjuvi Work for Follicular Lymphoma?
Monjuvi is a type of medicine known as a monoclonal antibody. Antibodies are proteins your immune system makes to help fight infection. The antibodies stick to proteins called antigens on the surfaces of cells. Different kinds of cells have different antigens. Only one kind of antibody fits each antigen, like a key in a lock. The antibodies mark the "bad" cells so your immune system can go after and destroy them. Monoclonal antibodies are made in a lab. They are designed to lock onto certain antigens that cancer cells make too much of.
Monjuvi helps the immune system find and destroy harmful B cells by attaching to a protein on the surface of B cells called CD19. Once Monjuvi attaches to CD19, it signals the immune system to attack and destroy those B cells. This can stop the cancer from growing or spreading.
Monjuvi is usually given with two other medicines, rituximab and lenalidomide. Rituximab is also a monoclonal antibody, but it looks for a different protein on B cells called CD20. Lenalidomide helps boost the immune system so it can fight cancer better.
How Do I Use Monjuvi?
Monjuvi is given by a health care provider as a slow infusion through a tube in your vein (called an IV). The infusion usually lasts 1½ to 2 hours. Before you have the infusion, you may receive other medicines to prevent side effects like a fever and chills.
Each treatment cycle of Monjuvi lasts for 28 days. For cycles one through three, Monjuvi is given on Days 1, 8, 15 and 22 of each cycle. For cycles four through twelve, Monjuvi is given on Days 1 and 15 of each cycle. Monjuvi is given along with two other medicines, rituximab and lenalidomide.
How Was Monjuvi Studied?
A clinical trial called inMIND was done to see if Monjuvi is safe and effective for the treatment of follicular lymphoma in adults. Monjuvi was compared to a placebo that contained no medicine. Most of the people in the trial did not know if they were getting Monjuvi or the placebo. People in both the Monjuvi and placebo groups received treatment with two other medicines, rituximab and lenalidomide. To be eligible for the trial, they had to have follicular lymphoma that came back or did not get better after previous treatment. People were not eligible for the trial if they had congestive heart failure or certain infections, or if they had already tried certain other medicines for their cancer.
The main goal of the trial was to find out how long people lived without their cancer getting worse or death (progression-free survival). The trial also looked at the number of people whose cancer could no longer be seen using imaging called a positron emission tomography (PET) scan (complete response), the number of people whose cancer got smaller or went away after treatment (overall response rate), and how long the cancer stayed smaller or went away after it first responded to treatment (duration of response).
The inMIND trial started in December 2020 and is still ongoing. As of 2024, a total of 548 adults with follicular lymphoma were included from multiple countries. People in the study were:
- Between the ages of 31 and 88 years, with 50% of people being 65 years and older
- Mostly men (55%)
- Mostly White (80%). Other races included Asian (15%), "other" (1%-2%), and 4% of people in the study did not report their race.
At the start of the trial:
- 19% to 22% of people had grade 1 follicular lymphoma
- 52% to 55% of people had grade 2 follicular lymphoma
- 25% to 26% of people had grade 3a follicular lymphoma
A lower-grade disease tends to be slow-growing, while a higher-grade disease can be fast-growing.
Also, 54% to 60% had tried other treatments for follicular lymphoma but had their cancer come back, and 35% to 41% did not respond to previous treatments for follicular lymphoma. Almost half of the people studied (48%) had tried two or more prior treatments. Lastly, 43% of people in the study did not respond to at least one prior therapy with a monoclonal antibody against CD20.
What Are the Main Benefits, Based on the inMIND Trial?
The inMIND trial is still ongoing. In an early look at the trial results after an average follow-up of 14.1 months, the group that received Monjuvi (plus rituximab and lenalidomide) for follicular lymphoma had an average progression-free survival of 22.4 months, compared to 13.9 months in the group that received the placebo (plus rituximab and lenalidomide). This means that people who received Monjuvi lived significantly longer without their cancer getting worse than those who did not receive Monjuvi.
Your results may differ from what was seen in clinical studies.
Are There Other Potential Benefits, Based on Trials?
The group that received Monjuvi had a 49.4% complete response rate, compared to 39.8% in the placebo group. This means that significantly more people in the Monjuvi group had no signs of cancer on their PET scans. Also, the group that received Monjuvi had an 83.5% overall response rate, compared to 72.4% in the placebo group. This means that significantly more patients who received Monjuvi had their cancer shrink or go away after treatment. Lastly, the average duration of response was 21.2 months in the group that received Monjuvi and 13.6 months in the group that received the placebo. This means that the cancer stayed away or smaller for a significantly longer time in people who took Monjuvi.
Your results may differ from what was seen in clinical studies.
How Strong Is the Evidence for Monjuvi?
Based on the inMIND trial, Monjuvi is safe and effective for adults with follicular lymphoma when used along with rituximab and lenalidomide. Current treatment guidelines support the use of Monjuvi as a preferred treatment for people with follicular lymphoma that came back or did not get better after previous treatment.
What Do We Know About Long-Term Safety?
The most common side effects of Monjuvi in people with follicular lymphoma are infections, diarrhea, rashes, fatigue, and constipation.
In the inMIND trial, people with follicular lymphoma took Monjuvi along with rituximab and lenalidomide for a maximum of 12 cycles. There were serious side effects in 19% of people, with viral infections being the most common (12%). Three patients died during treatment, two from COVID-19 and one from a blood infection. Monjuvi treatment was temporarily paused in 67% of people studied due to side effects. The most common reasons for pausing treatment were low white blood cell count (37%), viral infections (24%), and bacterial infections (5%). Monjuvi treatment was also permanently discontinued in 8% of people in the trial, mostly because of viral infections (4%) and fevers (1%).
What Can I Do to Manage Side Effects?
Watch for infusion reactions. If you notice symptoms like chills, a fever, rashes, shortness of breath, or dizziness during or soon after your infusion, tell your health care provider right away. To help prevent these reactions, you may be given other medicines before the infusion starts. If you do have a severe infusion reaction, your health care provider may need to slow down the Monjuvi infusion, temporarily pause your treatment, or stop Monjuvi completely.
Watch for signs of an infection. Take your temperature if you feel unwell. Call your health care provider right away if your temperature is 100.4 F or higher. Let your provider know if you have chills, a cough, a sore throat, or any new or worsening symptoms. If needed, you will receive medicine to treat the infection.
Look for signs of bleeding or bruising. Tell your health care provider right away if you see unusual bruises, bleeding gums, nosebleeds, or tiny red spots on your skin.
Go to all blood test appointments. You will need regular blood counts to check for low blood cells during treatment. During treatment with Monjuvi, your health care provider may also give you medicine called a "granulocyte colony-stimulating factor" to help your body make more white blood cells. If your blood counts are very low, your health care provider may temporarily pause your treatment or stop Monjuvi completely.
