Abstract
The oncogenic transcription inhibitor lurbinectedin (ZEPZELCA™) is being developed by PharmaMar as a treatment for various cancers. The drug has been granted orphan drug status for the treatment of small cell lung cancer (SCLC) by regulatory authorities in multiple countries worldwide and was approved in the USA in June 2020 for the treatment of adult patients with metastatic SCLC with disease progression on or after platinum-based chemotherapy. The US FDA and international regulators, including the Australian Therapeutic Goods Administration, are collaborating on the review of lurbinectedin under the Project Orbis initiative. Clinical investigation in other solid cancers is ongoing. This article summarizes the milestones in the development of lurbinectedin leading to this first approval for the treatment of metastatic SCLC.
Publication types
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Historical Article
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Review
MeSH terms
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Adult
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Australia
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Carbolines / administration & dosage*
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Carbolines / adverse effects
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Carbolines / history
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Clinical Trials as Topic
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Disease Progression
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Drug Administration Schedule
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Drug Approval / history*
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Drug Approval / statistics & numerical data
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Drug Development / history*
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Drug Development / legislation & jurisprudence
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Heterocyclic Compounds, 4 or More Rings / administration & dosage*
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Heterocyclic Compounds, 4 or More Rings / adverse effects
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Heterocyclic Compounds, 4 or More Rings / history
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History, 21st Century
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Humans
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Infusions, Intravenous
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Lung Neoplasms / drug therapy*
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Orphan Drug Production / history
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Orphan Drug Production / legislation & jurisprudence
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Small Cell Lung Carcinoma / drug therapy*
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United States
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United States Food and Drug Administration / legislation & jurisprudence
Substances
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Carbolines
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Heterocyclic Compounds, 4 or More Rings
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PM 01183