Each bubble represents a different industrial sponsor. Bubble size represents the number of Phase I–III clinical trials for that sponsor. The analysis includes all trial status and geography. Credit: GlobalData.

At the 2017 American Society of Hematology (ASH) conference, fms-like tyrosine kinase (FLT3) inhibitors were one of the key classes of targeted therapies showing encouraging clinical results in acute myeloid leukemia (AML) patients.

Based on the analysis of company sponsors currently running clinical trials with FLT3 inhibitors, four companies are clearly leading their development: Novartis, Astellas, Daiichi, and Arog, with 19, 14, 10, and nine Phase I–III trials, respectively.

While Novartis’ Rydapt (midostaurin) is now approved both in the US and EU, GlobalData forecasts FLT3 inhibitors with higher target specificity, such as Astellas’ quizartinib, Daiichi’s gilteritinib, and Arog’s crenolanib, to be widely adopted across the seven major markets (US, France, Germany, Italy, Spain, UK, and Japan).

Rydapt won the first US approval in the first-line setting; however, due to the small patient pool targeted in this setting (less than 8% of all AML patients), GlobalData forecasts the sales of the highly specific FLT3 inhibitors, gilteritinib and quizartinib, to exceed Rydapt’s sales.

Therefore, major clinical and commercial opportunities remain for FLT3 inhibitors, and GlobalData anticipates fierce competition among the four leading developers will arise in early 2019.