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Acute Myeloid Leukaemia: Update Bulletin #2 [July 2018]

Product Code:
Publication Date:
July 2018

This edition presents the views and insights from three world leading key opinion leaders (KOLs) from North America and Europe on a variety of recent events in the acute myeloid leukaemia (AML) market, including;  Daiichi Sankyo publishing Phase III data from the QuANTUM-R study, investigating its FLT3 kinase inhibitor quizartinib in patients with relapsed/refractory FLT3-mutated AML; Agios Pharma presenting updated results at ASCO 2018 from a Phase I study investigating its IDH1 inhibitor Tibsovo (ivosidenib) in patients with relapsed/refractory IDH1-mutated AML; and the FDA announcing that it had accepted with Priority Review status, the new drug application (NDA) for Astellas’ FLT3 and AXL kinase inhibitor gilteritinib in patients with relapsed/refractory FLT3-mutated AML. 

Business Questions:

• What are KOL perceptions on the positive overall survival data reported for quizartinib in the salvage relapsed/refractory patient setting?
• How significant do KOLs view the results with quizartinib in this patient population?
• In terms of the safety data published in QuANTUM-R, how do the experts view quizartinib? Do they harbour any concerns about QTcF prolongation?
• Do KOLs consider further development of quizartinib justified as a front-line therapy in the QuANTUM-First study?
• How will quizartinib compete with Novartis’ Rydapt (midostaurin) and other next-generation FLT3 inhibitors in the future?
• How do KOLs view the recent data presented at ASCO 2018 for Agios’ Tibsovo (ivosidenib)?
• How confident are KOLs about ivosidenib’s approval prospects in AML?
• What settings will be most relevant for future treatment with IDH inhibitors?
• Are experts keen to incorporate IDH inhibitors as part of combinations or as monotherapy?
• How do the KOLs view the FDA acceptance of the NDA for Astellas’ gilteritinib and what are their key thoughts on the ongoing Phase III ADMIRAL study?
• According to the KOLs, what differentiates gilteritinib from both Rydapt and quizartinib?
• With competition mounting in the FLT3 inhibitor space, which FLT3 drug may emerge superior, and what other factors will be important to ensure market uptake?


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