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Orelabrutinib: First Approval

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Abstract

Dysregulation of Bruton's tyrosine kinase (BTK) signalling has been linked to various B cell malignancies and autoimmune diseases. Orelabrutinib (宜诺凯®) is an orally administered, potent, irreversible and highly selective BTK-inhibitor being developed by InnoCare Pharma for the treatment of B cell malignancies and autoimmune diseases. In December 2020, orelabrutinib received its first approval in China for the treatment of patients with mantle cell lymphoma (MCL) or chronic lymphocytic leukaemia (CLL)/small lymphocytic lymphoma (SLL), who have received at least one treatment in the past. Clinical development of orelabrutinib for various indications is underway in the USA and China. This article summarizes the milestones in the development of orelabrutinib leading to this first approval.

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Funding

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

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

    Sohita Dhillon

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  1. Sohita Dhillon
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Correspondence to Sohita Dhillon.

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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 is a contracted employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.

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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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Dhillon, S. Orelabrutinib: First Approval. Drugs 81, 503–507 (2021). https://doi.org/10.1007/s40265-021-01482-5

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  • DOI: https://doi.org/10.1007/s40265-021-01482-5

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