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Umbralisib: First Approval

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posted on 21.03.2021, 23:45 by Sohita Dhillon, Susan J. Keam


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

Authorship and Conflict of interest 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. Sohita Dhillon, a contracted employee of Adis International Ltd/Springer Nature and Susan Keam, a salaried employee of Adis International Ltd/Springer Nature declare no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.

Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability Not applicable.

Additional information about this Adis Drug Review can be found here


Umbralisib (UKONIQ™) is an oral, first-in-class dual phosphatidylinositol 3-kinase delta (PI3Kδ) and casein kinase 1 epsilon (CK1ε) inhibitor being developed by TG Therapeutics for the treatment of various haematological malignancies. In February 2021, umbralisib received its first approval in the USA for the treatment of adults with relapsed or refractory marginal zone lymphoma (MZL) who have received ≥ 1 prior anti-CD20-based regimen, and relapsed or refractory follicular lymphoma (FL) who have received ≥ 3 prior lines of systemic therapy. Clinical studies in various haematological malignancies, including chronic lymphocytic leukaemia and non-Hodgkin lymphoma, are underway in multiple countries. This article summarizes the milestones in the development of umbralisib leading to this first approval.

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