ZEPZELCA
ZEPZELCA (lurbinectedin) is an alkylating drug indicated for the treatment of adult patients with small cell lung cancer (SCLC). It is indicated as maintenance therapy in combination with atezolizumab (or atezolizumab and hyaluronidase-tqjs) for patients with extensive-stage SCLC (ES-SCLC) whose disease has not progressed following first-line induction therapy with an atezolizumab-containing regimen, carboplatin, and etoposide. Additionally, ZEPZELCA is indicated as a monotherapy for adult patients with metastatic SCLC who have experienced disease progression during or after platinum-based chemotherapy. This second indication was granted under accelerated approval based on overall response rate and duration of response; continued approval may be contingent upon verification of clinical benefit in confirmatory trials.
How ZEPZELCA Works
Lurbinectedin is an alkylating drug that binds to guanine residues within the minor groove of DNA, forming adducts that bend the DNA helix toward the major groove. This structural deformation triggers a cascade of events that interferes with the activity of DNA-binding proteins, including specific transcription factors and DNA repair pathways, resulting in cell cycle perturbation and eventual apoptosis. Beyond its direct cytotoxic effects, lurbinectedin has been shown to inhibit human monocyte activity and reduce macrophage infiltration in tumor microenvironments.
Details
- Status
- Prescription
- First Approved
- 2020-06-15
- Routes
- INTRAVENOUS
- Dosage Forms
- POWDER
ZEPZELCA Approval History
What ZEPZELCA Treats
2 indicationsZEPZELCA is approved for 2 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Small Cell Lung Cancer
- Metastatic Small Cell Lung Cancer
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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.
ZEPZELCA FDA Label Details
ProIndications & Usage
FDA Label (PDF)ZEPZELCA is an alkylating drug indicated: • in combination with atezolizumab or atezolizumab and hyaluronidase-tqj, for the maintenance treatment of adult patients with extensive-stage small cell lung cancer whose disease has not progressed after first-line induction therapy with atezolizumab or atezolizumab and hyaluronidase-tqjs, carboplatin and etoposide. • For the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. This indication is approved under accelerated approval based on overall response rate and...
ZEPZELCA Patents & Exclusivity
Patents (5 active)
Exclusivity
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.