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Acalabrutinib: First Global Approval

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Abstract

Acerta Pharma is developing the Bruton’s tyrosine kinase inhibitor acalabrutinib (Calquence®) for the treatment of various haematological and solid malignancies. The drug has received accelerated approval from the US FDA for the treatment of mantle cell lymphoma based on the results of a phase II study, and phase III trials in mantle cell lymphoma and chronic lymphocytic leukaemia are currently underway. This article summarizes the milestones in the development of acalabrutinib leading to this first approval for mantle cell lymphoma.

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Authors and Affiliations

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

    Anthony Markham & Sohita Dhillon

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  1. Anthony Markham
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  2. Sohita Dhillon
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Correspondence to Sohita Dhillon.

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Funding

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

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. A. Markham is a contracted employee and S. Dhillon is a salaried employee of Adis/Springer. They are responsible for the article content, and declare no relevant conflicts of interest.

Additional information about this Adis Drug Review can be found at http://www.medengine.com/Redeem/24FCF060581038CF.

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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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Markham, A., Dhillon, S. Acalabrutinib: First Global Approval. Drugs 78, 139–145 (2018). https://doi.org/10.1007/s40265-017-0852-8

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