Monjuvi for lymphoma: how tafasitamab is used in care

Monjuvi is a prescription medicine used in combination with lenalidomide to treat certain adults with relapsed or refractory diffuse large B?cell lymphoma in the United States, according to the US prescribing information approved by the FDA in July 2020Incyte/MorphoSys, 07/2020FDA, 07/2020.

Updated: 05/19/2026 | Reading time: approx. 9 minutes

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

What Monjuvi Is and How It Works

Monjuvi, known generically as tafasitamab-cxix, is a CD19-directed cytolytic antibody used with lenalidomide to treat adults with relapsed or refractory diffuse large B-cell lymphoma who cannot receive an autologous stem cell transplant, as described in the US prescribing informationIncyte/MorphoSys, 07/2020FDA, 07/2020.

The medicine is a monoclonal antibody engineered to target the CD19 protein found on B cells, allowing immune mechanisms to attack these cancerous cells, according to the mechanism description in the US label and the joint company summaryIncyte/MorphoSys, 07/2020Incyte, 07/2020.

Monjuvi is given as an intravenous infusion in cycles that combine tafasitamab-cxix with oral lenalidomide followed by tafasitamab-cxix alone, according to the dosing schedule in the US prescribing informationIncyte/MorphoSys, 07/2020FDA, 07/2020.

Why Monjuvi Matters for Consumers and Industry

Monjuvi matters because it offers a treatment option for adults in the US with diffuse large B-cell lymphoma that has come back or not responded to prior therapy and who are not eligible for autologous stem cell transplant, as described in the FDA approval notice and US labelFDA, 07/2020Incyte/MorphoSys, 07/2020.

The treatment received accelerated approval from the FDA based on response data from a clinical study in adults with relapsed or refractory diffuse large B-cell lymphoma, as reported by the agency and company announcement, with continued approval depending on confirmatory trialsFDA, 07/2020Incyte, 07/2020.

For US oncologists and cancer centers, Monjuvi adds a targeted antibody option in a setting where many patients have already received at least one line of treatment, which is highlighted in US oncology coverage discussing CD19-directed therapies for diffuse large B-cell lymphomaNCI, 08/2020OncLive, 07/2020.

Monjuvi in the US and Global Market

Monjuvi is commercialized for US patients by Incyte under a collaboration with Morphosys, focusing on adults with relapsed or refractory diffuse large B-cell lymphoma who are not candidates for autologous stem cell transplant, as noted in the companies press material and the FDA approval summaryIncyte, 07/2020Morphosys, 07/2020.

US oncology practices may order Monjuvi through specialty distributors, and the brand maintains a patient support program to help eligible individuals access the medicine, according to information provided in US market materials and the product site access pageMonjuvi US site, 2023Incyte, 2023.

Outside the United States, tafasitamab is available under the name Minjuvi in some regions, reflecting broader global development of the antibody, according to communications from the companies and European regulatory materials, although specific indications and labels can differ by countryMorphosys, 2021EMA, 2021.

• CD19-directed monoclonal antibody for B-cell lymphoma
• Used with lenalidomide for certain adults with relapsed or refractory DLBCL
• Intravenous infusion given in repeating treatment cycles
• Approved in the US under accelerated approval by FDA
• Commercialized in the US by Incyte with Morphosys collaboration

Frequently Asked Questions About Monjuvi

Who is Monjuvi for in the United States?
Monjuvi is for adults with relapsed or refractory diffuse large B-cell lymphoma who are not eligible for autologous stem cell transplant, when used with lenalidomide, based on the US label and FDA approval noticeIncyte/MorphoSys, 07/2020FDA, 07/2020.

How is Monjuvi given?
Monjuvi is given as an intravenous infusion on a specific schedule in combination with oral lenalidomide at first, then as monotherapy, following the dosing instructions in the US prescribing information for tafasitamab-cxixIncyte/MorphoSys, 07/2020NCI, 08/2020.

Is Monjuvi available outside the US?
Tafasitamab is available as Minjuvi in some regions outside the United States with indications defined by regional regulators, according to company press releases and the European Medicines Agency product page, and details depend on local approvalsMorphosys, 2021EMA, 2021.

Monjuvi is co-developed by Morphosys and Incyte, with Incyte responsible for commercialization in the United States according to the companies collaboration announcements and product information materialsIncyte, 07/2020Morphosys, 07/2020.

Morphosys AG, associated with Monjuvi, has its shares listed on public markets and identified by ISIN DE0006632003, according to the company investor information and exchange dataMorphosys, 2023Borse Frankfurt, 2023.

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