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Loncastuximab tesirine (Zynlonta) is a CD19 ADC with a DNA-crosslinking payload for relapsed large B-cell lymphoma.
Loncastuximab tesirine (Zynlonta) is a humanised anti-CD19 antibody carrying SG3199, a pyrrolobenzodiazepine (PBD) dimer that forms interstrand DNA crosslinks, through a cleavable valine-alanine linker at a drug-to-antibody ratio of about 2.3. It is given at 0.15 mg/kg every 3 weeks for two cycles, then 0.075 mg/kg, with dexamethasone premedication, for relapsed or refractory DLBCL after two or more lines. Accelerated approval in 2021 rested on LOTIS-2 (objective response rate 48 percent), and the EU granted conditional authorisation in 2022. PBD payloads are extremely potent but bring oedema and effusions, photosensitivity, thrombocytopenia and raised GGT, toxicities that have limited the class in solid tumours. Its place alongside CD19 CAR-T and CD20 bispecifics remains to be settled. It is a CD19-directed ADC with a DNA-crosslinking payload for lymphoma that has come back.
Humanised anti-CD19 with PBD dimer; interstrand DNA crosslinks. Connects to CD19.
1.Antibody binds CD19 on the tumour cell surface
Source: www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications. Doses are for orientation; the current label governs.
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.
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.
Sources: NICE TA947. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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Treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low grade lymphoma, and high-grade B-cell lymphoma.
Accelerated approval, relapsed/refractory DLBCL after ≥2 lines (LOTIS-2) The confirmatory requirement was still open 5.4 years later, when the FDA's table was read. source
Conditional marketing authorisation source
| Region | Year | Indication |
|---|---|---|
| US | 2021 | Relapsed/refractory DLBCL after ≥2 systemic therapies |
| EU | 2022 | R/R DLBCL ≥2 lines (conditional) |
| Adverse event |
|---|
| Thrombocytopenia |
| Increased GGT |
| Neutropenia |
| Anaemia |
| Fatigue |
| Oedema and effusions |
| Photosensitivity/rash |
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.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Medicare Part B (physician-administered); commercial plans per formulary | not disclosed | - |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
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Query for this drug: (TITLE:"Loncastuximab tesirine" OR ABSTRACT:"Loncastuximab tesirine" OR TITLE:"Zynlonta" OR ABSTRACT:"Zynlonta") 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 Loncastuximab tesirine, not a curated reading list.
Shares CD19 expression (CD19-positive), CD19, Antibody-drug conjugate (ADC), Diffuse large B-cell lymphoma.
Shares CD19 expression (CD19-positive), What the NHS in England funds for lymphoma, appraisal by appraisal, CD19.
Shares CD19 expression (CD19-positive), What the NHS in England funds for lymphoma, appraisal by appraisal, CD19, Diffuse large B-cell lymphoma.
Shares CD19 expression (CD19-positive), What the NHS in England funds for lymphoma, appraisal by appraisal, CD19, Diffuse large B-cell lymphoma.
Shares CD19, Diffuse large B-cell lymphoma.
Shares DNA crosslinker payloads (PBD dimers), PBD dimer (SG3199 / tesirine), Antibody-drug conjugate (ADC).
Shares CD19, Antibody-drug conjugate (ADC).
Shares CD19, Diffuse large B-cell lymphoma.