Product Description
Lurbinectedin is a novel anticancer agent that inhibits transactivated transcription and modulates tumor microenvironment. Lurbinectedin showed high activity for patients with second-line SCLC when treated in combination with doxorubicin (Sourced from: https://www.iaslc.org/iaslc-news/press-release/lurbinectedin-does-not-improve-overall-survival-sclc-some-positive-action)
Mechanisms of Action: DNA Degrader
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Intravenous
FDA Designation: Accelerated Approval - Lung Cancer|Oncology Solid Tumor Unspecified|Small Cell Lung Cancer *
Approval Status: Approved
Approved Countries: Australia | Canada | Ecuador | Greece | Israel | Korea | Singapore | Sweden | Switzerland | United Arab Emirates | United States
Approved Indications: Lung Cancer | Oncology Solid Tumor Unspecified | Small Cell Lung Cancer | Oncology Unspecified
Known Adverse Events: Labor Pain | Pain Unspecified | Anemia | Leukopenia | Lymphopenia | Thrombocytopenia | Neutropenia | Musculoskeletal Pain | Constipation | Diarrhea
Company: Jazz
Company Location: DUBLIN L2 4
Company CEO: Bruce C. Cozadd
Additonal Commercial Interests: PharmaMar
Clinical Description
Countries in Clinic: Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Denmark, France, Georgia, Germany, Greece, Hungary, Israel, Italy, Japan, Korea, Mexico, Poland, Romania, South Korea, Spain, Switzerland, Taiwan, Turkey, United Kingdom, United States
Active Clinical Trial Count: 26
Highest Development Phases
Phase 3: Leiomyosarcoma|Lung Cancer|Small Cell Lung Cancer
Phase 2: Desmoplastic Small Round Cell Tumor|Gastrointestinal Cancer|Neuroendocrine Carcinoma|Oncology Solid Tumor Unspecified|Sarcoma, Ewing|Small Cell Sarcoma|Transitional Cell Carcinoma
Phase 1: Liver Cancer|Ovarian Cancer
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
---|---|---|---|---|---|
2015-003602-16 | P2 |
Active, not recruiting |
Oncology Solid Tumor Unspecified |
2029-11-30 |
|
PM1183-C-010-22 | P3 |
Unknown Status |
Leiomyosarcoma |
2029-04-30 |
|
LY01017/CT-CHN-302 | P3 |
Recruiting |
Small Cell Lung Cancer |
2027-12-31 |
|
EMERGE 101 | P2 |
Recruiting |
Sarcoma, Ewing |
2026-12-01 |