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).
- 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.
- Assistance programmes
- IncyteCARES
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
- Leukemia & Lymphoma Society financial support
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.
- 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.
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- 31 Jul 2020ApprovalUS
L-MIND accelerated approval
- Mar 2026Filing / dealUS
sBLA for frontline high-risk DLBCL (frontMIND) planned H1 2026 source
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2020 | R/R DLBCL with lenalidomide, transplant-ineligible (accelerated) |
| US | 2025 | R/R follicular lymphoma with lenalidomide and rituximab |
| Adverse event | Any grade | Grade 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
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
Latest papers
topQuery 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.
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