New Treatment Approved for Follicular Lymphoma: Tafasitamab-cxix (Monjuvi)

On June 18, 2025, the U.S. Food and Drug Administration (FDA) approved a one-year treatment combination of tafasitamab-cxix (Monjuvi, Incyte) with rituximab and lenalidomide for people whose follicular lymphoma has come back or stopped responding to previous treatment (relapsed/refractory).

In this article, you’ll learn how tafasitamab-cxix works, what the research shows about the combination’s effectiveness, and how it may be used as part of your care.

“Follicular lymphoma is generally an indolent yet chronic cancer that frequently recurs after treatment, making long-term disease control a critical objective. The FDA approval of Monjuvi in combination with rituximab and lenalidomide marks a significant advancement, offering a chemotherapy-free option that has demonstrated a meaningful reduction in the risk of disease progression across a broad patient population, including those with high-risk disease.” - Christina Poh, MD, Assistant Professor of Medicine at the University of Washington and Fred Hutchinson Cancer Center. 

How tafasitamab-cxix targets follicular lymphoma

Tafasitamab-cxix belongs to a group of therapies called antibody-drug conjugates (ADCs). Other approved ADCs for people with follicular lymphoma include polatuzumab vedotin-piiq (Polivy, Genentech) and loncastuximab tesirine-lpyl (Zynlonta, ADC Therapeutics SA). 

ADCs are made of a monoclonal antibody linked to an anti-cancer drug. The antibody carries the drug to a specific protein found on cancer cells. 

In the case of tafasitamab-cxix, it attaches to the surface protein CD19 on follicular lymphoma cells. This ADC not only delivers treatment to kill the cancer directly, but also signals the body’s immune system to help target the cancer. 

Tafasitamab-cxix is given in combination with rituximab and lenalidomide. Rituximab is another monoclonal antibody that targets a different protein called CD20. Lenalidomide supports the immune system. This multi-angle approach strengthens the overall treatment effect. 

How effective is tafasitamab-cxix for people with follicular lymphoma? 

In the inMIND study, 548 people with relapsed/refractory follicular lymphoma received rituximab and lenalidomide combined with either tafasitamab-cxix or a placebo. 

Since starting treatment, the median amount of time patients lived without the cancer getting worse (known as progression-free survival) was 22.4 months with tafasitamab-cxix, compared to 13.9 months without it. 

This means that patients who received the tafasitamab-cxix combination had better outcomes than those who received rituximab and lenalidomide alone. 

What to expect during treatment

Tafasitamab-cxix is given through an intravenous (IV) infusion. Lenalidomide is a pill, and rituximab is also given via IV infusion. People with relapsed/refractory follicular lymphoma receive this combination for a maximum of about one year (twelve 28-day cycles). 

In the first three months, tafasitamab-cxix is infused four times each month. After that, the number of monthly infusions is reduced to twice a month.

Understanding the schedule and delivery of treatment can help you plan around clinic visits and understand how long you might be on therapy. 

Managing side effects

Common side effects reported in the tafasitamab-cxix group included respiratory tract infections, diarrhea, rash, fatigue or weakness, muscle and bone pain, constipation, and cough. 

About one-third (33%) of patients experienced side effects that required hospital care (grade 3/4). These included infusion reactions, low blood cell counts, and infections. To lower the risk of infusion-related side effects, you’ll receive medicines before, such as acetaminophen and corticosteroids. 

To learn more about how side effects are managed, talk with your follicular lymphoma specialist. 

Summary

Tafasitamab-cxix, combined with rituximab and lenalidomide, is a newly approved one-year therapy for people with relapsed/refractory follicular lymphoma. Adding the antibody-drug conjugate helps improve treatment effectiveness by directly targeting cancer cells and activating the immune system. 

Study results showed the tafasitamab-cxix combination controlled follicular lymphoma from progressing for a significantly longer period of time than for patients who took rituximab and lenalidomide alone. Talk with your care team to evaluate if this treatment combination may be right for you. 

Continue Reading Follicular Lymphoma News

Sources: 

• FDA Approves Tafasitamab-cxix for Relapsed or Refractory Follicular Lymphoma
• Incyte Announces FDA Approval of Monjuvi® (tafasitamab-cxix) in Combination with Rituximab and Lenalidomide for Patients with Relapsed or Refractory Follicular Lymphoma
• NIH | Antibody-Drug Conjugate
• Monjuvi Prescribing Information
• Monjuvi MOA