NDAINTRAVENOUSPOWDERPriority Review
Approved
Jun 2020
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
Priority Review
ZEPZELCA (lurbinectedin) by Jazz Pharmaceuticals is alkylating activity [moa]. Approved for small cell lung cancer. First approved in 2020.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZEPZELCA (lurbinectedin) is an intravenous alkylating agent approved in 2020 for small cell lung cancer and expanding into 19+ solid tumor indications including ovarian cancer, sarcomas, and neuroendocrine tumors. It works by alkylating DNA, disrupting tumor cell replication and survival. The drug represents Jazz Pharmaceuticals' entry into the broad oncology alkylating agent space with potential across multiple cancer types.
$2.0MPart D
Peak14.1 years to LOEProduct is at peak commercial maturity with modest Medicare claims volume, indicating a focused niche market with limited team expansion opportunities relative to blockbuster comparators.
Mechanism of Action
Alkylating Activity
Pharmacologic Class:
Alkylating Drug
Indications (1)
Clinical Trials (20)
Lurbinectedin With Osimertinib in Transformed Small Cell Lung Cancer
Started May 2026
16 enrolled
Small Cell Lung Cancer ( SCLC )Transformed Small Cell Lung Cancer
A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC
Started Apr 2026
50 enrolled
Extensive-stage Small-cell Lung Cancer
Neoadjuvant Lurbinectedin and Preoperative Radiation for Treating Soft Tissue Sarcomas
Started Oct 2024
0Locally Advanced Soft Tissue Sarcoma
Lurbinectedin or in Combination with Irinotecan Versus Topotecan in Patients with Relapsed SCLC
Started Sep 2024
180 enrolled
Relapsed Small Cell Lung Cancer
Lurbinectedin Combined With Durvalumab in Pre-treated Patients With Extensive Stage Small-cell Lung Cancer
Started Oct 2023
0Small Cell Lung CancerPlatinum-Sensitive Lung Small Cell CarcinomaExtensive-stage Small-cell Lung Cancer
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.