OnCo
drugsProductApproved2021🇪🇺🇬🇧🇨🇳

Loncastuximab tesirine

Loncastuximab tesirine (Zynlonta) is a CD19 ADC with a DNA-crosslinking payload for relapsed large B-cell lymphoma.

Approved 2021 for relapsed/refractory DLBCL after ≥2 lines (LOTIS-2, ORR 48%). PBD payloads are extremely potent but carry oedema, photosensitivity, and effusion toxicity, limiting the class in solid tumours.

Loading structure…
|
Payload: SG3199 (PBD dimer)
PubChem
How it works, step by step · animated schematic, not to scale
Antibody-drug conjugate (ADC)
Mechanism, step by step
auto-advancing · hover to pause

1.Antibody binds CD19 on the tumour cell surface

Modality
ADC
Mechanism
Humanised anti-CD19 with PBD dimer; interstrand DNA crosslinks.
Brand / code
Zynlonta
Payload
SG3199 (PBD dimer, DNA crosslinker), DAR ~2.3
Linker
Val-Ala, cleavable
Dosing & schedule
Route
IV infusion
Schedule
0.15 mg/kg every 3 weeks for 2 cycles, then 0.075 mg/kg every 3 weeks; dexamethasone premedication
Dose modifications
Hold for grade ≥3 oedema/effusion or cytopenias
Monitoring
Weight and fluid status, blood counts, LFTs, photosensitivity precautions

Source: www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications. Doses are for orientation; the current label governs.

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
MHRA-licensed 2023 for relapsed or refractory DLBCL; NICE position not yet researched.

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

Regulatory

2top
  1. 23 Apr 2021ApprovalUS

    Accelerated approval, relapsed/refractory DLBCL after ≥2 lines (LOTIS-2) source

  2. Dec 2022ApprovalEU

    Conditional marketing authorisation source

Approvals

RegionYearIndication
US2021Relapsed/refractory DLBCL after ≥2 systemic therapies

Safety

7top
Toxicity profile
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.

Cost & access

1top
Cost & access
CountryReimbursement
United StatesMedicare Part B (physician-administered); commercial plans per formulary

List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.

Trials

top
ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
22 studies10 recruiting21 Phase 22 Phase 3
Search “Loncastuximab tesirine” 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
Loncastuximab tesirine
intervention: Loncastuximab tesirine
Open on ClinicalTrials.gov →

Country and place are remembered in this browser only. A postcode is sent to OpenStreetMap's Nominatim service to find coordinates when you press the button; nothing else leaves your device.

Latest papers

top
Literature trend16 papers in the last 12 months-30% vs prior 12How this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

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.

Connected

8top