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Ceritinib: First Global Approval

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Abstract

Ceritinib is an oral anaplastic lymphoma kinase (ALK) inhibitor developed by Novartis for the treatment of tumours characterised by genetic abnormalities in ALK. ALK is a member of the insulin receptor family of tyrosine kinases that can become oncogenic when fused to other proteins. Ceritinib has been approved in the US under ‘Breakthrough Therapy’ designation for the second-line treatment of ALK-positive non-small cell lung cancer (NSCLC). Regulatory submissions have also been made in the EU and other countries. Phase III development is ongoing worldwide to evaluate ceritinib both as a first- and second-line therapy for ALK-positive NSCLC. This article summarizes the milestones in the development of ceritinib leading to this first approval for the treatment of patients with ALK-positive metastatic NSCLC who have progressed on or are intolerant to crizotinib.

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Disclosure

The preparation of this report was not supported by any external funding. During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. S. Dhillon and M. Clarke are salaried employees of Adis, Springer SBM.

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Authors and Affiliations

  1. Adis, Level 1, 5 The Warehouse Way, Northcote, 0627, Auckland, New Zealand

    Sohita Dhillon & Madeleine Clark

  2. Adis, Private Bag 65901, Mairangi Bay, 0754, Auckland, New Zealand

    Sohita Dhillon

Authors
  1. Sohita Dhillon
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  2. Madeleine Clark
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Corresponding author

Correspondence to Sohita Dhillon.

Additional information

This profile has been extracted and modified from the Adis R&D Insight drug pipeline database. Adis R&D Insight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch.

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Dhillon, S., Clark, M. Ceritinib: First Global Approval. Drugs 74, 1285–1291 (2014). https://doi.org/10.1007/s40265-014-0251-3

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  • DOI: https://doi.org/10.1007/s40265-014-0251-3

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