Quizartinib supplemental new drug application submitted in Japan for patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia
Daiichi Sankyo announced that it has submitted a supplemental New Drug Application (sNDA) to Japan’s Ministry of Health, Labour and Welfare (MHLW) for quizartinib in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy and as continuation monotherapy for the treatment of adult patients in Japan with newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML)
“There is continued need in Japan for new therapeutic options to improve survival for patients with FLT3ITD positive acute myeloid leukemia, which is an aggressive and difficult-to-treat subtype,” said Wataru Takasaki, PhD, Executive Officer, Head of R&D Division in Japan, Daiichi Sankyo. “Quizartinib has potential to change the current standard of care as the first FLT3 inhibitor approved in Japan for patients with newly diagnosed FLT3-ITD positive AML. We look forward to working with the Japan MHLW with the aim to bring quizartinib to physicians and patients in this new indication as soon as possible.
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