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Duvelisib: First Global Approval

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Abstract

Duvelisib (Copiktra™) is a small-molecule inhibitor of phosphatidylinositol-3 kinase that has been developed as an oral treatment for various cancer indications. In September 2018, duvelisib received its first global approval in the USA for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukaemia (CLL)/small lymphocytic lymphoma (SLL) after at least two prior therapies. Duvelisib was also granted accelerated approval in the USA for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. Clinical development for various haematological malignancies is ongoing worldwide, as well as preclinical development for solid tumours in the USA. This article summarizes the milestones in the development of duvelisib leading to these first approvals for CLL/SLL and FL.

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Authors and Affiliations

  1. Springer, Private Bag 65901, Mairangi Bay, 0754, Auckland, New Zealand

    Hannah A. Blair

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  1. Hannah A. Blair
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Correspondence to Hannah A. Blair.

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Funding

The preparation of this review was not supported by any external funding.

Conflicts of interest

During the peer review process the manufacturer of duvelisib was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the author on the basis of scientific completeness and accuracy. Hannah Blair is a salaried employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.

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This profile has been extracted and modified from the AdisInsight database. AdisInsight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch and beyond.

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Blair, H.A. Duvelisib: First Global Approval. Drugs 78, 1847–1853 (2018). https://doi.org/10.1007/s40265-018-1013-4

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