Astellas' New Drug Gilteritinib Nears NMPA Approval for FLT3-Mutated Relapsed/Refractory AML in China

On January 27, the official website of the National Medical Products Administration (NMPA) indicated that the marketing application for Astellas’ gilteritinib fumarate tablets (gilteritinib) (Acceptance No.: JXHS2000033) had entered the “under review” stage, with approval from the NMPA expected in the near future. The drug is administered orally once daily for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who are positive for FLT3 mutations (FLT3mut+).

Gilteritinib, co-developed by Astellas and Kotobuki Pharmaceutical, is a FMS-like tyrosine kinase 3 (FLT3) inhibitor that inhibits two common FLT3 mutations (FLT3-ITD and FLT3-TKD) found in approximately one-third of patients with acute myeloid leukemia.

Gilteritinib Structural Formula

Gilteritinib was approved for marketing in Japan and the United States in 2018, respectively, for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) harboring FLT3 mutations. It is the first FLT3 inhibitor approved by the U.S. Food and Drug Administration (FDA) for relapsed or refractory AML.

To date, five relevant studies on gilteritinib have yielded clinical trial results, including four with positive outcomes and one with suboptimal efficacy.

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Astellas’ marketing authorization application for gilteritinib in China was accepted by the Center for Drug Evaluation (CDE) on April 11 and included in the priority review program on April 17, with approval expected in less than 10 months.

Source: PharmaCube PharmaGo