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Zepzelca
Published
Product name
Zepzelca
Active ingredient
Lurbinectedin
Submission type
New chemical entity
Decision
Approved for provisional registration
Decision date
Registration date
What this medicine was approved for
Zepzelca (lurbinectedin) was approved for the following therapeutic use:
Zepzelca is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) that has progressed on or after prior platinum-containing therapy. This indication was approved via the provisional approval pathway, based on objective response rate and duration of response in a single arm trial. Continued approval for this indication depends on verification and description of clinical benefit in a confirmatory trial.
How this medicine works
Lurbinectedin is an alkylating drug that binds guanine residues in the minor groove of deoxyribonucleic acid (DNA), forming adducts and resulting in a bending of the DNA helix towards the major groove. Adduct formation triggers a cascade of events that can affect the subsequent activity of DNA binding proteins, including some transcription factors, and DNA repair pathways, resulting in perturbation of the cell cycle and eventual cell death.Lurbinectedin inhibited human monocyte activity in vitro and reduced macrophage infiltration in implanted tumours in mice.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Zepzelca was considered favourable for the therapeutic use approved.