Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Lurbinectedin
Drug ID BADD_D02566
Description Lurbinectedin is a DNA alkylating agent that has been investigated in the treatment of a variety of cancers, including mesothelioma,[A214325] chronic lymphocytic leukemia (CLL),[A214328] breast cancer,[A214322] and small-cell lung cancer (SCLC).[A214310] It is a derivative of the marine-derived agent ecteinascidin ([trabectedin]), an anticancer agent found in extracts of the tunicate _Ecteinascidia turbinata_, with the primary difference being the substitution of the tetrahydroisoquinoline with a tetrahydro β‐carboline that results in increased antitumour activity of lurbinectedin as compared to its predecessor.[A214331] On June 15, 2020, the FDA granted accelerated approval and orphan drug designation to lurbinectedin for the treatment of adult patients with metastatic SCLC who have experienced disease progression despite therapy with platinum-based agents.[L14336] This accelerated approval is based on the rate and duration of therapeutic response observed in ongoing clinical trials and is contingent on the verification of these results in confirmatory trials.
Indications and Usage Lurbinectedin is indicated for the treatment of adult patients with metastatic small-cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.[L14327]
Marketing Status approved; investigational
ATC Code L01XX69
DrugBank ID DB12674
KEGG ID D11644
MeSH ID C568606
PubChem ID 57327016
TTD Drug ID D0V6OA
NDC Product Code 69112-102; 68727-712; 69443-018
UNII 2CN60TN6ZS
Synonyms PM 01183 | PM01183 | PM-01183 | lurbinectedin
Chemical Information
Molecular Formula C41H44N4O10S
CAS Registry Number 497871-47-3
SMILES CC1=CC2=C(C3C4C5C6=C(C(=C7C(=C6C(N4C(C(C2)N3C)O)COC(=O)C8(CS5)C9=C(CCN8)C2=C(N9) C=CC(=C2)OC)OCO7)C)OC(=O)C)C(=C1OC)O
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal pain07.01.05.0020.000627%
Anaemia01.03.02.0010.000526%
Asthenia08.01.01.0010.001119%Not Available
Atrial fibrillation02.03.03.0020.000112%
Blister23.03.01.001; 12.01.06.0020.000168%Not Available
Death08.04.01.0010.002630%
Extravasation08.01.03.0080.001063%Not Available
Febrile neutropenia08.05.02.004; 01.02.03.0020.000224%
Myalgia15.05.02.0010.000381%
Nausea07.01.07.0010.001366%
Neutropenia01.02.03.0040.000750%Not Available
Pancytopenia01.03.03.0030.000112%Not Available
Phlebitis24.12.03.004; 12.02.01.0020.000627%
Pneumonitis22.01.01.0060.000168%
Respiratory failure22.02.06.002; 14.01.04.0030.000112%
Rhabdomyolysis15.05.05.0020.000112%
Thrombocytopenia01.08.01.0020.000448%Not Available
Thrombophlebitis24.01.02.0010.000112%Not Available
Tumour lysis syndrome16.32.03.002; 14.05.01.0040.000336%
Vein disorder24.03.02.0150.000381%Not Available
Vomiting07.01.07.0030.000414%
Infusion site erythema23.03.06.016; 12.07.05.009; 08.02.05.0080.000302%Not Available
Peripheral swelling02.05.04.015; 08.01.03.0530.000112%Not Available
Malignant neoplasm progression16.16.01.0050.000448%Not Available
Infusion site pain12.07.05.002; 08.02.05.0140.000414%Not Available
Infusion site swelling12.07.05.003; 08.02.05.0020.000358%Not Available
Lung neoplasm malignant22.08.01.001; 16.19.02.0010.000168%Not Available
Metastases to central nervous system16.22.02.004; 17.02.10.0130.000224%Not Available
Haematotoxicity12.03.01.025; 01.05.01.0070.000381%Not Available
Neoplasm progression16.16.02.0050.000112%Not Available
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