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Zepzelca (LURBINECTEDIN)
Zepzelca works by attaching an alkyl group to DNA, which interferes with DNA replication and causes cell death.
Zepzelca (Lurbinectedin) is a small molecule alkylating drug developed by JAZZ, currently owned by Jazz Pharmaceuticals. It was FDA-approved in 2020 for the treatment of small cell carcinoma of the lung. As an alkylating agent, Zepzelca works by interfering with DNA replication, ultimately leading to cell death. The drug has a half-life of 51 hours and is not yet available as a generic. Key safety considerations include its potential for myelosuppression and hepatotoxicity.
At a glance
| Generic name | LURBINECTEDIN |
|---|---|
| Sponsor | Jazz Pharmaceuticals |
| Drug class | Alkylating Drug [EPC] |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2020 |
Mechanism of action
Lurbinectedin is an alkylating drug that binds guanine residues in the minor groove of DNA, forming adducts and resulting in bending of the DNA helix towards the major groove. Adduct formation triggers cascade of events that can affect the subsequent activity of DNA binding proteins, including some transcription factors, and DNA repair pathways, resulting in perturbation of the cell cycle and eventual cell death. Lurbinectedin inhibited human monocyte activity in vitro and reduced macrophage infiltration in implanted tumors in mice.
Approved indications
- Small cell carcinoma of lung
Common side effects
- Leukopenia
- Lymphopenia
- Fatigue
- Anemia
- Neutropenia
- Increased creatinine
- Increased alanine aminotransferase
- Increased glucose
- Thrombocytopenia
- Nausea
- Decreased appetite
- Musculoskeletal pain
Key clinical trials
- A Study to Evaluate the Optimal Dose, Adverse Events and Change in Disease Activity of Intravenous ABBV-706 in Combination With Atezolizumab Versus Standard of Care as First-Line Treatment in Adult Participants With Previously Untreated Extensive Stage Small Cell Lung Cancer (PHASE2)
- Lurbinectedin With or Without Avelumab in Small Cell Carcinoma of the Bladder (LASER) (PHASE2)
- Lurbinectedin With Berzosertib, an ATR Kinase Inhibitor in Small Cell Cancers and High-Grade Neuroendocrine Cancers (PHASE1,PHASE2)
- A Study of ZL-1310 Versus Investigator's Choice of Therapy in Participants With Relapsed Small Cell Lung Cancer (DLLEVATE) (PHASE3)
- Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Participants With Metastatic Leiomyosarcoma (SaLuDo) (PHASE3)
- Biomarker Directed Trial of Temozolomide and Stenoparib in Relapsed SCLC (PHASE1,PHASE2)
- A Phase III, Open-Label Study of Maintenance Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab in Participants With Extensive-Stage Small-Cell Lung Cancer (PHASE3)
- A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
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:
- Zepzelca CI brief — competitive landscape report
- Zepzelca updates RSS · CI watch RSS
- Jazz Pharmaceuticals portfolio CI