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Zynlonta (LONCASTUXIMAB)
Zynlonta works by binding to a specific target on cancer cells, marking them for destruction.
LONCASTUXIMAB (Zynlonta), marketed by ADC Therapeutics SA, is approved for treating relapsed or refractory large B-cell lymphoma. Its key strength lies in its mechanism of action, which targets and marks cancer cells for destruction, providing a precise therapeutic approach. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | LONCASTUXIMAB |
|---|---|
| Sponsor | ADC Therapeutics SA |
| Modality | Monoclonal antibody |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2022 |
Mechanism of action
Loncastuximab tesirine-lpyl is an antibody-drug conjugate (ADC) targeting CD19. 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 is SG3199, a PBD dimer and alkylating agent. Upon binding to CD19, loncastuximab tesirine-lpyl is internalized followed by release of SG3199 via proteolytic cleavage. The released SG3199 binds to the DNA minor groove and forms highly cytotoxic DNA interstrand crosslinks, subsequently inducing cell death. Loncastuximab tesirine-lpyl had anticancer activity in animal models of lymphoma.
Approved indications
- relapsed or refractory large B-cell lymphoma
- diffuse large B-cell lymphoma (DLBCL) not otherwise specified
- DLBCL arising from low-grade lymphoma
- high-grade B-cell lymphoma
Common side effects
- Thrombocytopenia
- Increased gamma-glutamyltransferase
- Neutropenia
- Anemia
- Hyperglycemia
- Transaminase elevation
- Fatigue
- Edema
- Nausea
- Musculoskeletal pain
- Rash
- Pleural effusion
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)
Patents
| Patent | Expiry | Type |
|---|---|---|
| Biologic Exclusivity |
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 |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Zynlonta CI brief — competitive landscape report
- Zynlonta updates RSS · CI watch RSS
- ADC Therapeutics SA portfolio CI