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LONCASTUXIMAB TESIRINE
LONCASTUXIMAB TESIRINE is a Antibody-Drug Conjugate (ADC) drug. It is currently FDA-approved (first approved 2021).
Loncastuximab tesirine is an ADC that targets CD19 on B-lineage cells, internalizes, and releases a cytotoxic agent to induce cell death.
Loncastuximab tesirine (ZYNLONTA) is an antibody-drug conjugate (ADC) targeting CD19, approved for treating relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy. It works by binding to CD19 on B-lineage cells, internalizing, and releasing a cytotoxic agent that induces cell death. Common side effects include thrombocytopenia, neutropenia, anemia, and fatigue. There are no contraindications, but it carries warnings for effusion, myelosuppression, infections, hepatotoxicity, and cutaneous reactions.
At a glance
| Generic name | LONCASTUXIMAB TESIRINE |
|---|---|
| Drug class | Antibody-Drug Conjugate (ADC) |
| Target | CD19 |
| Modality | Antibody drug conjugate |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2021 |
Mechanism of action
The monoclonal IgG1 kappa antibody component binds to human CD19, a transmembrane protein expressed on the surface of cells of B-lineage origin. The small molecule component, SG3199, is a PBD dimer and alkylating agent that forms highly cytotoxic DNA interstrand crosslinks upon release, leading to cell death.
Approved indications
Boxed warnings
- Effusion and Edema
- Myelosuppression
- Infections
- Hepatotoxicity, including DILI
- Cutaneous Reactions
Common side effects
- Thrombocytopenia
- Increased gamma-glutamyltransferase
- Neutropenia
- Anemia
- Hyperglycemia
- Transaminase elevation
- Fatigue
- Hypoalbuminemia
- Rash
- Edema
- Nausea
- Musculoskeletal pain
Key clinical trials
- Study to Evaluate Loncastuximab Tesirine With Rituximab Versus Immunochemotherapy in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (PHASE3)
- Loncastuximab Tesirine in Combination With Rituximab in Patients With Relapsed or Refractory Follicular Lymphoma (PHASE2)
- A Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination With Other Anti-cancer Agents in Participants With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (LOTIS-7) (PHASE1)
- Epcoritamab in Combination With Loncastuximab Tesirine in Relapsed/Refractory Large B-cell Lymphoma (PHASE2)
- A Global Study of Novel Agents in Paediatric and Adolescent Relapsed and Refractory B-cell Non-Hodgkin Lymphoma (PHASE2, PHASE3)
- A Study of MT-2111 in Patients With Relapsed/Refractory DLBCL (PHASE1, PHASE2)
- Loncastuximab Tesirine and Venetoclax for Relapsed/ Refractory Non-Hodgkin Lymphoma (PHASE1)
- A Phase II Study of Loncastuximab Tesirine as Consolidation Strategy in Patients With LBCL in PR After CAR T-cell Therapy (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- LONCASTUXIMAB TESIRINE CI brief — competitive landscape report
- LONCASTUXIMAB TESIRINE updates RSS · CI watch RSS
Frequently asked questions about LONCASTUXIMAB TESIRINE
What is LONCASTUXIMAB TESIRINE?
How does LONCASTUXIMAB TESIRINE work?
What drug class is LONCASTUXIMAB TESIRINE in?
When was LONCASTUXIMAB TESIRINE approved?
What development phase is LONCASTUXIMAB TESIRINE in?
What are the side effects of LONCASTUXIMAB TESIRINE?
What does LONCASTUXIMAB TESIRINE target?
Related
- Drug class: All Antibody-Drug Conjugate (ADC) drugs
- Target: All drugs targeting CD19
- Therapeutic area: All drugs in Oncology
- Compare: LONCASTUXIMAB TESIRINE vs similar drugs
- Pricing: LONCASTUXIMAB TESIRINE cost, discount & access