FDA issues CRL on quizartinib NDA

24 June 2019

Japanese drugmaker Daiichi Sankyo (TYO: 4568) saw its shares rise 3.25% to 5,977 yen today, despite revealing that its blood cancer drug candidate quizartinib had encountered a delay in US approval.

The company said it has received a Complete Response Letter (CRL) from the US Food and Drug Administration for the New Drug Application (NDA) of quizartinib for the treatment of adults with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML).

"Daiichi Sankyo is evaluating the Complete Response Letter and will determine next steps in the US," Dr said Antoine Yver, executive vice president and global head, oncology R&D at Daiichi Sankyo.

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