Fostamatinib: First Global Approval
- 329 Downloads
Rigel Pharmaceuticals are developing the spleen tyrosine kinase (SYK) inhibitor fostamatinib (TAVALISSE™) as a treatment for immune thrombocytopenia (ITP), autoimmune haemolytic anaemia and IgA nephropathy. Based on positive results in the phase III FIT clinical trial program, the drug was recently approved in the US as a treatment for thrombocytopenia in adult patients with chronic ITP who have had an insufficient response to a previous treatment. This article summarizes the milestones in the development of fostamatinib leading to this first approval.
Compliance with Ethical Standards
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 author on the basis of scientific completeness and accuracy. A. Markham, a contracted employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.
- 1.Rigel Pharmaceuticals Inc. Fostamatinib (Tavalisse™): US prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209299lbl.pdf (2018). Accessed 9 May 2018.
- 2.Rigel Pharmaceuticals Inc. Rigel earns milestone payments from AstraZeneca [media release]. 29 Sept 2010. http://www.rigel.com.
- 3.Rigel Pharmaceuticals Inc. Rigel will resume responsibility for fostamatinib program [media release]. 4 Jun 2013. http://www.rigel.com.
- 7.Martin P, Gillen M, Millson D, et al. Effects of CYP3A4 inhibitors ketoconazole and verapamil and the CYP3A4 inducer rifampicin on the pharmacokinetic parameters of fostamatinib: results from in vitro and phase I clinical studies. Drugs R D. 2016;16(1):81–92.CrossRefPubMedPubMedCentralGoogle Scholar
- 13.Kuter DJ, Arnold D, Agajanian R, et al. Fostamatinib, a spleen tyrosine kinase inhibitor, is active in the treatment of warm antibody autoimmune hemolytic anemia: results of the SOAR phase 2, multicenter, open-label study [poster]. In: 4th biennial summit of the thrombosis & hemostasis societies of North America. 2018.Google Scholar
- 14.Rigel Pharmaceuticals Inc. Rigel announces topline data from proof-of-concept phase 2 study of fostamatinib in IgA nephropathy [media release]. 3 Apr 2018. http://www.rigel.com.