FREQUENTLY ASKED QUESTIONS ABOUT MONJUVI
What is MONJUVI?
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*
*MONJUVI is a CD19-directed cytolytic monoclonal antibody.1
When was MONJUVI approved?
MONJUVI, in combination with lenalidomide, received initial US approval in 2020, and was granted accelerated approval based on the 1-year primary analysis of the L-MIND study. The data for the 3-year analysis of the L-MIND study has not yet been submitted to or reviewed by the FDA. The status with respect to potential inclusion of these data in the final, FDA-approved labeling has yet to be determined. See the full Prescribing Information.
Who is eligible for treatment with MONJUVI?
MONJUVI is second-line targeted immunotherapy for adult patients with DLBCL who are ineligible for transplant.1* Review profiles of candidates for treatment with MONJUVI.
*MONJUVI is a CD19-directed cytolytic monoclonal antibody.1
How was MONJUVI studied?
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.
What types of patients were included in the MONJUVI clinical trial?
L-MIND examined patients with a broad range of characteristics, including those considered difficult-to-treat.1 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.
What were the response rates for MONJUVI in the clinical trial?
Response rates in the L-MIND clinical trial were assessed in a 1-year primary analysis as well as a 3-year follow-up. More than half of the patients in the 1-year primary analysis and the 3-year follow-up achieved either complete or partial remission.1,3
MONJUVI, in combination with lenalidomide, was granted accelerated approval based on the 1-year primary analysis of the L-MIND study. The data for the 3-year analysis of the L-MIND study has not yet been submitted to or reviewed by the FDA. The status with respect to potential inclusion of these data in the final, FDA-approved labeling has yet to be determined. Explore L-MIND efficacy results.
What was the duration of response seen in patients treated with the combination of MONJUVI and lenalidomide during the clinical trial?
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 3-year follow-up analysis, the median DoR was 43.9 months (95% CI: 15.0, NR).3†‡
MONJUVI, in combination with lenalidomide, was granted accelerated approval based on the 1-year primary analysis of the L-MIND study. The data for the 3-year analysis of the L-MIND study has not yet been submitted to or reviewed by the FDA. The status with respect to 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.1,3
What are the important warnings and precautions for MONJUVI?
MONJUVI can cause serious adverse reactions including:
- Infusion-Related Reactions: Monitor patients frequently during infusion. Interrupt or discontinue infusion based on severity
- 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
- 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
- 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.
Which adverse reactions were most commonly seen in the MONJUVI clinical trial?
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.
Dosage and Administration
How is MONJUVI + lenalidomide administered?
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.
Are dosage modifications of MONJUVI recommended for managing adverse reactions?
For details on modifying the dose of MONJUVI to help manage adverse reactions, please see the full Prescribing Information.
Is MONJUVI chemotherapy?
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. Tafasitamab-cxix is given in combination with lenalidomide for the first year of treatment.1 Read more about how MONJUVI works.
Where can I find more information about MONJUVI?
You can find more information about MONJUVI, including detailed guides and videos, on the Educational Materials page.
How can I help my patients keep track of their treatment schedule?
You can help patients keep track of their treatment schedule by creating a treatment calendar.
Billing and Coding
What is the J-code for MONJUVI?
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.
What financial and educational support programs are available for MONJUVI?
Financial and educational support are available for eligible patients through The My MISSION Support Program, which aims to make treatment with MONJUVI affordable.