Daiichi Sankyo’s FLT3 Inhibitor VANFLYTA Approved by the FDA in the US.
On July 20, 2023, Daiichi Sankyo Company, Limited – a global pharmaceutical giant, announced that for the treatment of adults with newly diagnosed FLT3 - ITD Positive Acute Myeloid Leukemia (AML) - an inhibitor, VANFLYTA (Quizartinib), has been approved by The US Food and Drugs Association in combination with anthracycline induction, standard cytarabine, and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy.
The FLT3 - ITD mutation is present in around
37% of patients with AML, which is a common Leukemia form in adults. This
mutation contributes to cancer growth and reduces the survival rate of
patients. However, the approval of Daiichi Sankyo’s VANFLYTA is a sign of
advancement in the treatment of patients with the mutation.
“The approval of VANFLYTA represents a significant advancement
for the treatment of patients with newly diagnosed FLT3-ITD
positive AML, which is one of the most aggressive and difficult-to-treat
subtypes”. - Harry P. Erba of the Duke Cancer Institute.
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For specific treatment of FLT3 – ITD Positive
AML, VANFLYTA is the first and only inhibitor approved by the FDA. It can be
administered in adults with FLT3 - ITD Positive AML without transplant through
induction, consolidation, and maintenance - the three stages of treatment
without a transplant.
“Today’s FDA approval of
VANFLYTA is an important milestone, as patients with the FLT3-ITD subtype
of AML can now be treated with the first-ever FLT3 inhibitor approved across
the three phases of treatment these patients typically receive,” – Ken
Keller, CEO, Daiichi Sankyo.
VANFLYTA has shown several benefits such as
longer remission and prolonged survival.
“In the QuANTUM-First trial, VANFLYTA added to standard
chemotherapy and continued as maintenance resulted in longer remission and
prolonged overall survival and it will be a much-needed new treatment option
that has the potential to change the way FLT3-ITD positive AML is
treated.” – Harry P.
Erba of the Duke Cancer Institute.
There are some contraindications of VANFLYTA as
well - including patients that have a history of torsades de pointes,
ventricular arrhythmias, or have long QT syndrome, hypokalemia, or severe
hypomagnesemia.
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