Daiichi Sankyo Vanflyta approved in EU as First FLT3 Inhibitor specifically for newly Diagnosed FLT3-ITD Positive AML

Tokyo: Daiichi Sankyo’s VANFLYTA (quizartinib) has been approved in the European Union (EU) for use in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by VANFLYTA single-agent maintenance therapy for adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive.

VANFLYTA is the first FLT3 inhibitor approved in the EU specifically for the treatment of patients with newly diagnosed FLT3-ITD positive AML, which represents about 25 to 30% of all new AML cases.

The authorization by the European Commission (EC) follows the positive opinion of the Committee for Medicinal Products for Human Use and is based on the results of the QuANTUM-First trial, which were published in The Lancet. In QuANTUM-First, VANFLYTA combined with standard cytarabine and anthracycline induction and standard cytarabine consolidation, and continued as maintenance monotherapy following consolidation, demonstrated a 22% reduction in the risk of death compared to standard chemotherapy alone (HR = 0.78 [95% CI: 0.62-0.98; p=0.032]) in patients with newly diagnosed FLT3-ITD positive AML. Median overall survival was 31.9 months for patients receiving VANFLYTA (n=268; 95% CI: 21.0-NE) compared to 15.1 months for patients in the control arm (n=271; 95% CI: 13.2-26.2) at a median follow-up of 39.2 months.

“This approval of VANFLYTA represents an important advancement for frontline treatment of patients with FLT3-ITD positive acute myeloid leukemia, an aggressive and historically difficult-to-treat subtype,” said Richard F. Schlenk, MD, Professor and Head of the Trial Center of the National Center of Tumour Diseases, Heidelberg University Hospital and German Cancer Research Center, Germany.

“VANFLYTA is a potent and selective FLT3 inhibitor that significantly improved overall survival when added to standard chemotherapy and it will be a valuable treatment option for newly diagnosed FLT3-ITD positive AML.” “This approval of VANFLYTA is very welcome news for eligible patients diagnosed with FLT3-ITD positive AML each year,” said Samantha Nier, Network Director, Acute Leukemia Advocates Network (ALAN).

“New medicines and treatment approaches are needed to help patients with this difficult type of leukemia live longer, and we look forward to VANFLYTA becoming available in countries throughout the EU.”

The safety profile of VANFLYTA in QuANTUM-First was consistent with previous clinical trials with no new safety signals observed.

“With the approval of VANFLYTA in the European Union, patients diagnosed with FLT3-ITD positive acute myeloid leukemia may for the first time receive a targeted therapy developed and approved specifically for their disease subtype,” said Ken Keller, Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, Inc. “VANFLYTA is the second innovative medicine from our oncology pipeline approved in the EU and its successful development reflects our commitment to creating new standards of care for patients with cancer.”

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