How Monjuvi helps treat relapsed or refractory DLBCL

Monjuvi is an antibody therapy used with lenalidomide for some adults with relapsed or refractory diffuse large B-cell lymphoma, offering a targeted option when standard treatments have failed.

Monjuvi is a prescription cancer medicine used with lenalidomide for certain adults with relapsed or refractory diffuse large B-cell lymphoma, providing a targeted antibody option alongside existing chemotherapy backbones in the United StatesFDA, 07/31/2020Monjuvi US Prescribing Information, 08/2023.

Updated: 05/17/2026 | Reading time: approx. 10 minutes

By the AD HOC NEWS editorial team - specialized in product-led market coverage.

At a Glance

• Product: Monjuvi
• Category: Anti-CD19 monoclonal antibody cancer therapy
• Brand/Manufacturer: Incyte; co-developed with MorphoSys
• Main Use Cases: Certain adults with relapsed or refractory diffuse large B-cell lymphoma
• Availability: Prescription only, hospital and specialty pharmacy distribution in the US
• Key Markets: United States oncology centers and hematology practices

What Monjuvi Is and How It Works

Monjuvi, known generically as tafasitamab-cxix in the US, is an antibody drug that targets the CD19 protein found on B cells, including many diffuse large B-cell lymphoma cellsMonjuvi HCP Site, 08/2023New England Journal of Medicine, 06/18/2020.

By binding to CD19, Monjuvi is designed to help the immune system recognize and attack malignant B cells. This process can complement the activity of lenalidomide, an oral immunomodulatory medicine used alongside Monjuvi in eligible patientsMonjuvi Dosing Guide, 08/2023Blood, 12/24/2020.

Monjuvi is given as an intravenous infusion on a schedule that includes more frequent dosing at the beginning of therapy, followed by less frequent maintenance infusions when the combination is continuedMonjuvi Patient Site, 08/2023Monjuvi Dosing Guide, 08/2023.

Why Monjuvi Matters for Consumers and Industry

For eligible adults in the United States whose diffuse large B-cell lymphoma has returned or not responded after at least one line of systemic therapy, Monjuvi with lenalidomide offers a non-chemotherapy-containing regimen before or when other options like CAR T-cell therapy are not suitableFDA, 07/31/2020American Cancer Society, 03/14/2024.

In clinical research used to support approval, investigators studied Monjuvi combined with lenalidomide in adults with relapsed or refractory diffuse large B-cell lymphoma who were not candidates for stem cell transplant, helping to define its role in patients with limited optionsNew England Journal of Medicine, 06/18/2020Blood, 12/24/2020.

From an industry perspective, Monjuvi illustrates how targeted antibodies and immunomodulatory drugs are being combined in community and academic oncology settings across the US, expanding treatment approaches beyond traditional chemotherapy-only protocolsNational Cancer Institute, 02/08/2021OncLive, 09/21/2021.

Monjuvi in the US and Global Market

In the United States, Monjuvi is marketed under a collaboration between Incyte and MorphoSys and distributed through specialty pharmacies and hospital systems that treat hematologic malignanciesIncyte Product Information, 09/2023Monjuvi US Prescribing Information, 08/2023.

The approval was granted under the FDA accelerated approval pathway, which links continued approval to confirmatory trial outcomes, underscoring the importance of ongoing research in diffuse large B-cell lymphomaFDA, 07/31/2020FDA, 05/04/2022.

Outside the US, tafasitamab-based therapies are also part of treatment discussions for certain diffuse large B-cell lymphoma populations, but availability, brand names, and approved indications can differ under regional regulatory decisionsEuropean Medicines Agency, 08/26/2021Haematologica, 03/2022.

• Intravenous antibody targeting CD19 on B cells
• Used with lenalidomide for some adults with relapsed or refractory diffuse large B-cell lymphoma
• Administered in US hospitals and infusion centers under oncologist supervision
• Approved through the FDA accelerated approval pathway

Frequently Asked Questions About Monjuvi

Who can receive Monjuvi in the US?
Monjuvi with lenalidomide is indicated for certain adults with relapsed or refractory diffuse large B-cell lymphoma who have had at least one prior line of systemic therapy and are not eligible for transplantMonjuvi US Prescribing Information, 08/2023.

How is Monjuvi given?
Monjuvi is infused into a vein at an oncology clinic or hospital, following a schedule that is more intensive in the first cycles and then becomes less frequent for maintenance if therapy continuesMonjuvi Dosing Guide, 08/2023.

Is Monjuvi chemotherapy?
Monjuvi is a monoclonal antibody, not traditional cytotoxic chemotherapy. It is part of a targeted immunotherapy approach when used with lenalidomide in eligible diffuse large B-cell lymphoma patientsAmerican Cancer Society, 03/14/2024.

Monjuvi is co-developed by MorphoSys and Incyte, with Incyte responsible for commercialization in the United States oncology marketMorphoSys Pipeline, 09/2023Incyte Product Information, 09/2023.

Shares of MorphoSys have been traded in Europe under ISIN DE0006632003, while Incyte is listed in the United States on Nasdaq under the ticker INCYMorphoSys Investor Relations, 03/2024Incyte Investor Relations, 03/2024.

Disclaimer: This article does not constitute investment advice. Stocks are volatile financial instruments.