Japanese pharmaceutical company Daiichi Sankyo recently announced it received a complete response letter (CRL) from the Food and Drug Administration (FDA) for the New Drug Application (NDA) of the cancer-fighting drug quizartinib.
The company has initiated a sweeping quizartinib development project coupled with chemotherapy that targets the newly diagnosed FLT3-ITD AML (QuANTUM-First) in the United States, EU and Japan.
"Daiichi Sankyo is evaluating the Complete Response Letter and will determine next steps in the U.S.," said Dr. Antoine Yver, Daiichi Sankyo executive vice president and global head of oncology research and development.
Quizartinib is Daiichi Sankyo’s flagship product in the treatment of relapsed/refractory FLT3-ITD adult acute myeloid leukemia (AML). Japan is the only country that has sanctioned the use of quizartinib.
AML is cancer found in blood and bone marrow that inhibits the production of blood cells due to the unconstrained growth and aggregation of dysfunctional, malignant white blood cells.
Daiichi Sankyo is a Tokyo, Japan-based company that develops, manufactures and sells pharmaceutical products and employs 15,000 people in 20 countries.
