Duvelisib: First Global Approval
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.
Compliance with Ethical Standards
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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