NDAINTRAVENOUSPOWDERPriority Review
Approved
Jun 2020
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
ZEPZELCA (lurbinectedin) by Jazz Pharmaceuticals is alkylating activity [moa]. First approved in 2020.
Drug data last refreshed 13h ago · AI intelligence enriched 18h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZEPZELCA (lurbinectedin) is an intravenous alkylating chemotherapy agent approved in June 2020 for oncology indications. It works through alkylating activity to disrupt DNA and inhibit cancer cell growth. The drug is currently in peak commercial lifecycle at Jazz Pharmaceuticals.
$0.002BPart D
Peak13.7 years to LOEProduct is at peak lifecycle with modest Part D utilization (158 claims, $2M spending in 2023), suggesting a niche market positioning with stable but limited commercial momentum.
Mechanism of Action
Alkylating Activity
Pharmacologic Class:
Alkylating Drug
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC
Started Nov 2026
50 enrolled
Extensive-stage Small-cell Lung Cancer
Lurbinectedin With Osimertinib in Transformed Small Cell Lung Cancer
Started Aug 2026
16 enrolled
Small Cell Lung Cancer ( SCLC )Transformed 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.