Acalabrutinib: First Global Approval

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

Conflicts of interest: Anthony Markham is a contracted employee of Adis/Springer, is responsible for the article contentand declares no relevant conflicts of interest.

Additional information about this Adis Drug Review can be found here.

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. Access to the full article can be found here.

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