FAQs

INDICATIONS & USAGE

MONJUVI (tafasitamab-cxix), in combination with lenalidomide, is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).

This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

MONJUVI is second-line targeted immunotherapy for adult patients with DLBCL who are ineligible for transplant.¹*

Read more about MONJUVI here or see the full Prescribing Information.

*MONJUVI is a CD19-directed cytolytic monoclonal antibody.¹

MONJUVI, in combination with lenalidomide, was granted accelerated approval in the US in 2020 based on the 1-year primary analysis of the L-MIND study. The 5-year analysis data from L-MIND have not been submitted to or reviewed by the FDA, and potential inclusion of these data in the final FDA-approved labeling has yet to be determined. See the full Prescribing Information.

MONJUVI is second-line targeted immunotherapy given in combination with lenalidomide for adult patients with DLBCL who are ineligible for transplant.¹*

*MONJUVI is a CD19-directed cytolytic monoclonal antibody.¹

L-MIND was an open-label, multicenter, single-arm, phase 2 study that evaluated the efficacy and safety of MONJUVI in combination with lenalidomide followed by MONJUVI monotherapy in adult patients with R/R DLBCL (confirmed by central laboratory) who were not eligible for or refused ASCT. Efficacy was established in 71 patients based on best ORR (CR + PR) and DoR, as assessed by an Independent Review Committee using the International Working Group Response Criteria (Cheson 2007).^1,2 Read more about the L-MIND study design.

L-MIND examined patients with a broad range of characteristics, including those considered difficult-to-treat.^1,3-4 Eligible patients had relapsed or refractory DLBCL after 1 to 3 prior systemic therapies, including a CD20-containing therapy. Enrolled patients at the time of the trial were not eligible for or refused autologous stem cell transplantation (ASCT).¹ Read more about the L-MIND study design.

Response rates in the L-MIND clinical trial were assessed in a 1-year primary analysis as well as a 5-year follow-up. More than half of the patients in the 1-year primary analysis and the 5-year follow-up achieved either complete or partial remission. For the primary 1-year analysis, the best ORR was 55% (CR: 37%; PR: 18% [n=39; 95% CI: 43%, 67%]).^1† For the 5-year analysis, the best ORR was 54% (CR: 37%; PR: 17% [n=38; 95% Cl: 41%, 66%]).^5†

MONJUVI, in combination with lenalidomide, was granted accelerated approval based on the 1-year primary analysis of the L-MIND study. The 5-year analysis data from L-MIND have not been submitted to or reviewed by the FDA, and potential inclusion of these data in the final FDA-approved labeling has yet to be determined. Explore L-MIND efficacy results.

^†Assessed by an Independent Review Committee.^1,5

Patients in the clinical trial demonstrated sustained remission. In the 1-year primary analysis, the median DoR was 21.7 months (range: 0, 24).^1‡§ In the 5-year follow-up analysis, the median DoR was not reached, with a median follow-up of 53.8 months.^6‡§

MONJUVI, in combination with lenalidomide, was granted accelerated approval based on the 1-year primary analysis of the L-MIND study. The 5-year analysis data from L-MIND have not been submitted to or reviewed by the FDA, and potential inclusion of these data in the final FDA-approved labeling has yet to be determined. Review duration of response results.

^‡Assessed by an Independent Review Committee.^1,6

^§Kaplan-Meier estimates.^1,6

MONJUVI can cause serious adverse reactions including:

1. Infusion-Related Reactions: Monitor patients frequently during infusion. Interrupt or discontinue infusion based on severity
2. Myelosuppression: MONJUVI can cause serious or severe myelosuppression, including neutropenia, thrombocytopenia, and anemia. Monitor complete blood counts. Manage using dose modifications and growth factor support. Interrupt or discontinue MONJUVI based on severity
3. Infections: Fatal and serious infections, including opportunistic infections, occurred in patients during treatment with MONJUVI and following the last dose. Bacterial, fungal, and viral infections can occur during and following MONJUVI. Monitor patients for infections and manage as appropriate
4. Embryo-Fetal Toxicity: May cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and use of effective contraception

Please see related and other Important Safety Information throughout this website.

The most common adverse reactions to MONJUVI and lenalidomide (≥20%) in the L-MIND clinical trial were neutropenia (51%), fatigue (38%), anemia (36%), diarrhea (36%), thrombocytopenia (31%), cough (26%), pyrexia (24%), peripheral edema (24%), respiratory tract infection (24%), and decreased appetite (22%).¹ See more safety and tolerability details from the L-MIND study.

MONJUVI is administered as an intravenous infusion by a healthcare professional. Lenalidomide is taken as a once-daily oral treatment.¹ Read more about dosage and administration of MONJUVI + lenalidomide.

For details on modifying the dose of MONJUVI to help manage adverse reactions, please see the full Prescribing Information.

No, MONJUVI is not chemotherapy. It is targeted immunotherapy that effectively binds to the CD19 antigen expressed on the surface of pre-B and mature B lymphocytes and in several B-cell malignancies, including DLBCL. MONJUVI is given in combination with lenalidomide for the first year of treatment.¹ Read more about how MONJUVI works.

You can find more information about MONJUVI, including detailed guides and videos, on the Educational Materials page.

You can help patients keep track of their treatment schedule by creating a treatment calendar.

The J-code for MONJUVI is J9349. For additional information, please see the billing and coding page of the site or download the full MONJUVI Billing and Coding Guide.