Abstract
Brigatinib (ALUNBRIG™) is a small molecule antineoplastic anaplastic lymphoma kinase (ALK) inhibitor being developed by ARIAD Pharmaceuticals (a wholly-owned subsidiary of Takeda Pharmaceutical Company). In April 2017 brigatinib received accelerated approval in the USA for the treatment of patients with ALK-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. The development of resistance to crizotinib is a therapeutic challenge that has led to the development of second-generation ALK-inhibitors such as brigatinib, which have activity against treatment-resistant ALK mutants. This article summarizes the milestones in the development of brigatinib leading to this first global approval for the treatment of patients with ALK-positive metastatic NSCLC who have progressed on or are intolerant to crizotinib.
This is a preview of subscription content, log in via an institution to check access.
Similar content being viewed by others
References
ARIAD Pharmaceuticals Inc. ARIAD announces issuance of key U.S. patent on brigatinib [media release] 22 Apr 2015. http://www.ariad.com.
Gettinger SN, Bazhenova LA, Langer CJ, et al. Activity and safety of brigatinib in ALK-rearranged non-small-cell lung cancer and other malignancies: a single-arm, open-label, phase 1/2 trial. Lancet Oncol. 2016;17(12):1683–96.
US FDA. Brigatinib [media release] 28 Apr 2017. http://www.fda.gov.
ARIAD Pharmaceuticals Inc. ARIAD announces submission of Marketing Authorization Application for brigatinib to the European Medicines Agency [media release] 6 Feb 2017. http://investor.ariad.com.
ARIAD Pharmaceuticals Inc. ARIAD to receive up to $200 million through Iclusig non-dilutive synthetic-royalty financing with PDL BioPharma [media release] 29 Jul 2015. http://www.ariad.com.
Takeda Pharmaceutical Company Limited. Takeda to acquire ARIAD Pharmaceuticals, Inc. [media release] 10 Jan 2017. https://www.takeda.com.
Takeda Pharmaceutical Company Limited. Takeda completes acquisition of ARIAD Pharmaceuticals, Inc. [media release] 17 Feb 2017. https://www.takeda.com.
ARIAD Pharmaceuticals Inc. ALUNBRIGTM (brigatinib): US prescribing information. 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208772lbl.pdf. Accessed 2 May 2017.
Zhang S, Anjum R, Squillace R, et al. The potent ALK inhibitor brigatinib (AP26113) overcomes mechanisms of resistance to first- and second-generation ALK inhibitors in preclinical models. Clin Cancer Res. 2016;22(22):5527–38.
Kim DW, Tiseo M, Ahn MJ, et al. Brigatinib in patients with crizotinib-refractory anaplastic lymphoma kinase-positive non-small-cell lung cancer: a randomized, multicenter phase II trial. J Clin Oncol. 2017. doi:10.1200/JCO.2016.71.5904.
Disclosure
The preparation of this review was not supported by any external funding. 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 author on the basis of scientific completeness and accuracy. A. Markham is a contracted employee of Adis, Springer SBM.
Additional information about this Adis Drug Review can be found at http://www.medengine.com/Redeem/4B48F06066ACFC3C.
Author information
Authors and Affiliations
Corresponding author
Additional information
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.
Rights and permissions
About this article
Cite this article
Markham, A. Brigatinib: First Global Approval. Drugs 77, 1131–1135 (2017). https://doi.org/10.1007/s40265-017-0776-3
Published:
Issue Date:
DOI: https://doi.org/10.1007/s40265-017-0776-3