OnCo
drugsProductApproved2020🇪🇺🇬🇧🇦🇺

Tafasitamab

A CD19 antibody given with lenalidomide for lymphoma patients who cannot have a transplant; in 2026 it showed the first frontline gain over R-CHOP in high-risk disease.

L-MIND (single arm, with lenalidomide): ORR 60%, CR 43%, median DOR ~44 months; accelerated approval July 2020 for transplant-ineligible R/R DLBCL. frontMIND phase 3 (Lancet 2026): tafasitamab + lenalidomide + R-CHOP vs placebo + R-CHOP in IPI 3-5 DLBCL; 2-year PFS 71.1% vs 62.9%, HR 0.75; OS immature (HR 0.85). Also approved 2025 with lenalidomide-rituximab in follicular lymphoma (inMIND).

Schematic of the modality · Monoclonal antibody (anti-CD19, Fc-enhanced) · not a molecule; see the Monoclonal antibodies page
Modality
Monoclonal antibody (anti-CD19, Fc-enhanced)
Mechanism
Fc-engineered (XmAb) anti-CD19 antibody with enhanced ADCC/ADCP; lenalidomide augments NK activity.
Brand / code
Monjuvi
Dosing & schedule
Route
IV
Schedule
12 mg/kg days 1, 8, 15, 22 of cycles 1-3, then days 1 and 15 from cycle 4; lenalidomide 25 mg days 1-21 for up to 12 cycles, tafasitamab until progression
Monitoring
Cytopenias, infections, infusion reactions
Medicare
Part B (clinician-administered)

Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies.

Commercial insurance
covered with prior authorisation

Covered under the medical benefit with prior authorisation confirming diagnosis, biomarker status and line of therapy; site-of-care policies may steer infusions away from hospital outpatient departments.

20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.

Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.

Not yet researchedSearch NICE
Notes
Licensed 2021 with lenalidomide for DLBCL; NICE appraisal terminated after the company did not submit. Not routinely funded. Check NICE.

Sources: NICE search: tafasitamab. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

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  1. 31 Jul 2020ApprovalUS

    L-MIND accelerated approval

  2. Mar 2026Filing / dealUS

    sBLA for frontline high-risk DLBCL (frontMIND) planned H1 2026 source

Approvals

RegionYearIndication
US2020R/R DLBCL with lenalidomide, transplant-ineligible (accelerated)
US2025R/R follicular lymphoma with lenalidomide and rituximab

Safety

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Toxicity profile
Adverse eventAny gradeGrade 3+
Neutropenia
48%
Thrombocytopenia
17%
Febrile neutropenia
12%

L-MIND, with lenalidomide. Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
49 studies17 recruiting45 Phase 25 Phase 3
Search “Tafasitamab” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Tafasitamab
intervention: Tafasitamab
Open on ClinicalTrials.gov →

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Landmark trials in OnCo

Latest papers

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Literature trend30 papers in the last 12 months+58% vs prior 12How this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Tafasitamab" OR ABSTRACT:"Tafasitamab" OR TITLE:"Monjuvi" OR ABSTRACT:"Monjuvi") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Tafasitamab, not a curated reading list.

Connected

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