Registered South Africa · SAHPRA

ZEPZELCA

LURBINECTEDIN

60/26/0188 INN generic

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Registration & product details

Registration no.
60/26/0188
Registration date
2026/10/13
Expiry date
-
Status
Registered
Active ingredient
LURBINECTEDIN
Dosage form
-
Strength
-
Pack size
-
Therapeutic class
-
Manufacturer / MAH
-
Applicant / LTR
Key Oncologics (Pty) Ltd
Country of origin
-

Source: South African Health Products Regulatory Authority · fetched 2026-10-28 04:13:08

Disclaimer: This information is sourced from South African Health Products Regulatory Authority (South Africa). Always consult a qualified healthcare professional before using any medication.

Molecular reference: lurbinectedin

PubChem CID 57327016

Molecular formula: C41H44N4O10S

Mechanism of action

Lurbinectedin is a DNA alkylating agent. It covalently binds to guanine residues in the DNA minor groove, forming adducts that bend the DNA helix towards the major groove. This process triggers a cascade of events that affect the activity of transcription factors and impairs DNA repair pathways, ultimately leading to double-strand DNA breaks and eventual cell death. Additional mechanism(s) of action include inhibition of RNA-polymerase-II activity, inactivation of Ewing Sarcoma Oncoprotein (EWS-FL11) via nuclear redistribution, and the inhibition of human monocyte activity and macrophage infiltration into tumor tissue.

Pharmacodynamics

Lurbinectedin exerts its chemotherapeutic activity by covalently binding to DNA, resulting in double-strand DNA breaks and subsequent cell death. Lurbinectedin has been associated with myelosuppression, and patients receiving therapy with this agent should be closely monitored for evidence of cytopenias. Prior to beginning therapy, ensure baseline neutrophil counts are >1,500 cells/mm<sup>3</sup> and platelet counts are >100,000/mm<sup>3</sup>. The supplementary use of granulocyte colony-stimulating factor (G-CSF) should be considered if the neutrophil count falls below 500 cells/mm<sup>3</sup>. Lurbinectedin has also been associated with hepatotoxicity. Monitor liver function tests at baseline and regular intervals throughout therapy, and consider holding, reducing, or permanently discontinuing therapy based on the severity of observed hepatotoxicity.

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.