Monjuvi (Tafasitamab): A Therapeutic Breakthrough in DLBCL

Introduction

Tafasitamab, a CD19-targeted cytolytic antibody, has received FDA accelerated approval in adult patients for the therapy of relapsed or refractory diffuse large B-cell lymphoma (DLBCL). This marks a significant advancement in DLBCL therapy. The approval was granted in July 2020 and represents a significant advancement in the therapy options available for this group of DLBCL patients. 

Uses

Monjuvi is used in conjunction with lenalidomide in the therapy of adult patients dealing with relapsed or refractory diffuse large B-cell lymphoma, which includes cases not otherwise specified. This applies to DLBCL originating from low-grade lymphoma and affecting those not qualified candidates for autologous stem cell transplant (ASCT).

Mechanism of Action

Tafasitamab (tafasitamab cxix) binds to CD19, a protein that is expressed on the B cell surface, and induces cell death through antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity.

Clinical Trials

The efficacy of Tafasitamab-cxix with lenalidomide was studied in L-MIND (NCT02399085), an open-label, multicenter single-arm trial in 81 patients. Patients received tafasitamab-cxix 12 mg/kg intravenously with lenalidomide (25mg orally on days 1 to 21 of each 28-day cycle) for a maximum of 12 cycles, followed by Tafasitamab-cxix as monotherapy. The overall response rate was 55%, with 37% of patients achieving a complete response.

Dosage

The medication is available as a lyophilized powder contained in a single-dose vial for reconstitution, with each vial containing 200mg of tafasitamab cxix. Administer premedications before starting Monjuvi injection. The recommended dosage is 12mg/kg via intravenous infusion on specified days within a 28-day cycle. 

Initially, the dosing schedule includes Cycle 1 (Days 1, 4, 8, 15, and 22). For Cycles 2 and 3, it involves Days 1, 8, 15, and 22. Subsequently, in Cycle 4 and beyond, administer on Days 1 and 15 of each 28-day cycle. Monjuvi should be combined with lenalidomide for a maximum of 12 cycles, followed by continued use as monotherapy until disease progression or unacceptable toxicity.

Warnings And Precautions

Tafasitamab may cause serious or fatal infusion-related reactions, cytokine release syndrome, and neurologic toxicities. Patients should be monitored for symptoms of these adverse reactions during and after infusion.

• Infusion-Related Reactions: Regularly monitor patients during infusion and consider interruption or discontinuation based on severity.
• Myelosuppression: Keep a close watch on complete blood counts and manage with dose adjustments and growth factor support. Interrupt or discontinue Monjuvi as needed based on the level of severity.
• Infections: Patients should be monitored for bacterial, fungal, and viral infections during and following Monjuvi treatment.
• Embryo-Fetal Toxicity: Inform females of reproductive potential about potential fetal risks and the importance of effective contraception due to the potential for fetal harm.

Recent Research

An ongoing Phase 2 clinical trial (NCT04276479) is investigating the use of tafasitamab in combination with rituximab and lenalidomide for patients with relapsed or refractory DLBCL.

Conclusion

FDA approval of Tafasitamab-cxix, known as Monjuvi, in treating DLBCL is a significant milestone in oncology. This therapeutic breakthrough represents a new avenue for patients facing this formidable challenge, providing fresh optimism and the potential for improved outcomes. As we progress, it underscores the importance of ongoing research and innovation as we strive to offer effective solutions and enhanced quality of life to individuals battling DLBCL. 

Ongoing research explores using tafasitamab in combination with other drugs for treating DLBCL. Monjuvi price in India depends on the product requirement. Request more details by contacting our Patient Support Team at ‎(+91) 9315705373 or help@sansfro.com.   

Reference

1. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761163s000lbl.pdf
2. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-tafasitamab-cxix-diffuse-large-b-cell-lymphoma https://www.cancer.gov/about-cancer/treatment/drugs/tafasitamab-cxix