Acalabrutinib: First Global Approval
Related Experiment Video
Updated: Feb 17, 2026

Scaled-Up Preparation of an Intermediate of Upatinib, ACT051-3
Published on: April 7, 2023
Anthony Markham1, Sohita Dhillon2
1Springer, Private Bag 65901, Mairangi Bay, 0754, Auckland, New Zealand.
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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