ZYNLONTA
Zynlonta (loncastuximab tesirine-lpyl) is a CD19-directed antibody-drug conjugate indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma. It is used after patients have undergone at least two lines of systemic therapy. The indication includes specific subtypes such as diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma. This drug received accelerated approval based on overall response rate, and continued approval may depend on the verification of clinical benefit in confirmatory trials.
How ZYNLONTA Works
Loncastuximab tesirine-lpyl is an antibody-drug conjugate that targets CD19, a protein found on the surface of B-lineage cells. After binding to CD19, the agent is internalized into the cell, where it releases a small molecule alkylating agent called SG3199 via proteolytic cleavage. SG3199 then binds to the DNA minor groove and forms highly cytotoxic interstrand crosslinks. This process disrupts the DNA and subsequently induces cell death in the targeted lymphoma cells.
Details
- Status
- Prescription
- First Approved
- 2021-04-23
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
ZYNLONTA Approval History
What ZYNLONTA Treats
3 indicationsZYNLONTA is approved for 3 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Large B-Cell Lymphoma
- Diffuse Large B-Cell Lymphoma
- High-Grade B-Cell Lymphoma
ZYNLONTA Target & Pathway
ProTarget
A protein expressed on B-cells throughout their development. CD19 is a key target for CAR-T cell therapies in B-cell leukemias and lymphomas, where engineered T-cells are directed to kill CD19-expressing cancer cells.
ZYNLONTA Competitors
Pro3 other drugs also target CD19. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (CD19). Earlier expiry dates signal biosimilar/generic opportunities.
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ZYNLONTA FDA Label Details
ProIndications & Usage
FDA Label (PDF)ZYNLONTA is indicated for the treatment of adult patients with relapsed or refractory 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. This indication is approved under accelerated approval based on overall response rate [see Clinical Studies ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ZYNLONTA is a CD19-directed antibody and alkylating ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.