EMA Accepts Daiichi Sankyo’s Marketing Application For Leukemia Drug

The European Medicines Agency (EMA) has accepted for review Daiichi Sankyo’s Marketing Authorization Application for quizartinib in combination with chemotherapy for the treatment of a common form of adult leukemia. 

If approved, quizartinib will be initially combined with cytarabine and anthracycline chemotherapy before being administered as a monotherapy. It is indicated to treat adult patients with acute myeloid leukemia (AML) whose cancers test positive for FMS-like tyrosine kinase 3 internal tandem duplication (FLT3-ITD). 

Quizartinib is currently approved in Japan to treat relapsed or refractory FLT3-ITD-positive AML, but has not been approved anywhere else. However, the drug has been granted Orphan Drug designation in Europe and the US, as well as a Fast Track Designation from the US FDA. 

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A Medical Need For AML Treatments

AML is a common form of adult leukemia, constituting about one-third of cases. Around 25% of newly-diagnosed AML cases carry the FLT3-ITD mutation, which is associated with increased risk of relapse and shorter overall survival. 

“There is a need to improve survival for the majority of patients with acute myeloid leukemia, particularly those with the FLT3-ITD subtype, which is aggressive and difficult to treat,” said Ken Takeshita, MD, Global Head of R&D at Daiichi Sankyo. 

An orally-administered drug, quizartinib works by blocking FLT3, a tyrosine kinase receptor that is expressed by blood stem cells. Blocking this receptor disrupts pathways necessary for cell development, growth, differentiation and survival. 

Daiichi Sankyo’s application is based on data from the QuANTUM-First Phase 3 trial recently presented at the European Hematology Association Congress 2022. In QuANTUM-First, the quizartinib combination (followed by monotherapy) demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) in adult patients with newly diagnosed FLT3-ITD positive AML compared to chemotherapy alone. 

On the safety front, quizartinib combined with chemotherapy and as continuation monotherapy in QuANTUM-First was generally manageable and consistent with previous clinical trials. 

Adverse effects of the treatment regimen include irregular heart contractions such as ventricular arrhythmia events. The risks were  manageable with ECG monitoring, quizartinib dose modification and correction or elimination of additional risk factors, the company said.

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Joy Lin

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