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01-01-2018 | AdisInsight Report

Acalabrutinib: First Global Approval

Authors: Anthony Markham, Sohita Dhillon

Published in: Drugs | Issue 1/2018

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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Acerta Pharma. Acerta Pharma announces strategic transaction with AstraZeneca [media release]. 17 Dec 2015. http://www.acerta-pharma.com.

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Wang M, Rule SA, Zinzani PL, et al. Efficacy and safety of acalabrutinib monotherapy in patients with relapsed/refractory mantle cell lymphoma in the phase 2 ACE-LY-004 study [abstract no. 155]. In: American Society of Hematology (ASH) 59th Annual Meeting and Exposition. 2017.

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Woyach J, Awan F, Jianfar M, et al. Acalabrutinib with obinutuzumab in relapsed/refractory and treatment-naive patients with chronic lymphocytic leukemia: the phase 1b/2 ACE-CL-003 study [abstract no. 432]. In: American Society of Hematology (ASH) 59th Annual Meeting and Exposition. 2017.

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18.

Byrd J, Owen R, O’Brien S, et al. Pooled Analysis of Safety Data from Clinical Trials Evaluating Acalabrutinib Monotherapy in Hematologic Malignancies [abstract no. 4326]. In: American Society of Hematology (ASH) 59th Annual Meeting and Exposition. 2017.

Title: Acalabrutinib: First Global Approval
Authors: Anthony Markham
Sohita Dhillon
Publication date: 01-01-2018
Publisher: Springer International Publishing
Published in: Drugs / Issue 1/2018
Print ISSN: 0012-6667
Electronic ISSN: 1179-1950
DOI: https://doi.org/10.1007/s40265-017-0852-8

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Acalabrutinib: First Global Approval

Abstract

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

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