Lurbinectedin: First Approval
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ADISINSIGHT REPORT
Lurbinectedin: First Approval Anthony Markham1
© Springer Nature Switzerland AG 2020
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.
Lurbinectedin (ZEPZELCA™): Key points An oncogenic transcription inhibitor is being developed by PharmaMar for the treatment of various cancers Received its first approval on June 15 2020 in the USA Approved for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.
1 Introduction Lurbinectedin (ZEPZELCA™) is an oncogenic transcription inhibitor being developed by PharmaMar as treatment for various solid tumours, including small cell lung cancer Enhanced material for this AdisInsight Report can be found at https://doi.org/10.6084/m9.figshare.12720926. This profile has been extracted and modified from the AdisInsight database. AdisInsight tracks drug development worldwide through the entire development process, from discovery, through preclinical and clinical studies to market launch and beyond. * Anthony Markham [email protected] 1
Springer Nature, Private Bag 65901, Mairangi Bay, Auckland 0754, New Zealand
(SCLC) [1]. The drug covalently binds to the central guanine of various nucleotide triplets in the minor groove of DNA forming adducts that are capable of inducing double-strand breaks, with this DNA damage ultimately leading to apoptotic cell death [2]. It is also thought to induce immunogenic cell death (ICD) and stimulate anti-cancer immunity [3]. Lurbinectedin has also been associated with a significant reduction in tumour-associated macrophages (TAMs) and thus may also have a direct effect on the tumour microenvironment [4]. Lurbinectedin has been granted orphan drug status for the treatment of SCLC by regulatory authorities in the USA [5], the EU [6] and Australia [7] and was recently approved in the USA (2 months ahead of the PDUFA date) [8] for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy [9]. The US FDA and international regulators, including the Australian Therapeutic Goods Administration, are collaborating on the review of lurbinectedin under the Project Orbis initiative [10].
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