AML [2017]: Bulletin #1
This update bulletin presents key opinion leader (KOL) views on recent developments in the acute myeloid leukaemia (AML) market. Topics covered include: Novartis receiving US FDA approval for Rydapt (midostaurin) in newly diagnosed FLT3-mutated AML; the US FDA placing a clinical hold on several early stage studies of Seattle Genetics’ novel anti-CD33 antibody drug conjugate vadastuximab talirine (SGN-CD33A) in patients with AML; and Agios Pharmaceuticals and Celgene announcing that the US FDA has accepted their New Drug Application (NDA) for enasidenib (AG-221) for the treatment of patients with relapsed/refractory AML with an isocitrate dehydrogenase 2 (IDH2) mutation.
Business Questions
Business Questions
- How do KOLs view the FDA approval of the first FLT3 inhibitor Novartis’ Rydapt in AML?
- Could Rydapt capture market share in a wider population of patients; e.g. those without FLT3-mutated AML?
- Do KOLs expect Rydapt to be utilised in the maintenance setting?
- How do KOLs view the trade-off between efficacy and the risk of hepatotoxicity and death with Seattle Genetics’ vadastuximab, and should development of the drug continue?
- How does vadastuximab compare to its discontinued predecessor Mylotarg?
- How will combination trials inform the best positioning for vadastuximab and its developmental pathway?
- What are the KOLs’ opinions on Agios/Celgene’s IDH2 inhibitor enasidenib in AML, and how likely is it that it will be approved this year by the US FDA?
- If approved, do KOLs expect niche or widespread use of enasidenib in AML?
- Will delays and logistical issues with companion diagnostic testing for targeted therapies be a barrier to use in the first-line setting of AML?
