Daiichi Sankyo gets CRL on leukemia med candidate

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that the company received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) 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 U.S.,” said Antoine Yver, MD, MSc, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo.

About Quizartinib
Quizartinib, an oral selective type II FLT3 inhibitor, is the lead product in the AML Franchise of Daiichi Sankyo. Quizartinib was approved by the Ministry of Health, Labor and Welfare (MHLW) of Japan under the brand name of VANFLYTA^® for the treatment of adult patients with relapsed/refractory FLT3-ITD AML, as detected by an MHLW-approved test, on June 18, 2019.

A broad and comprehensive development program is underway with quizartinib including phase 3 development in combination with standard chemotherapy in newly diagnosed FLT3-ITD AML (QuANTUM-First) in the U.S., EU and Japan; phase 1/2 development for pediatric and young adult relapsed/refractory FLT3-ITD AML in North America and the EU; and phase 1 development in combination with an investigational MDM2 inhibitor, milademetan, for relapsed/refractory FLT3-ITD AML and newly-diagnosed FLT3-ITD AML unfit for intensive chemotherapy in the U.S.

Milademetan is an investigational agent that has not been approved for any indication in any country. Safety and efficacy have not been established. Quizartinib is only approved for use in Japan.

https://www.biospace.com/article/releases/daiichi-sankyo-provides-update-on-fda-review-of-quizartinib-for-the-treatment-of-patients-with-relapsed-refractory-flt3-itd-aml/