Astellas Announces NMPA Approval of Gilteritinib in China for Relapsed or Refractory FLT3-Mutated AML

Source: Medical Insight

According to the latest public announcement on the official website of China’s National Medical Products Administration (NMPA), the status of the marketing application for Astellas’ gilteritinib fumarate tablets (Xospata, gilteritinib) in China has been updated to “Approval Completed – Pending Certificate Issuance,” with the drug approval number: Guoyao Zhunzi HJ20210009. This indicates that this clinically urgent new drug has been approved in China. According to earlier disclosures by the NMPA’s Center for Drug Evaluation (CDE), the indicated indication is for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) harboring FLT3 mutations.

Screenshot source: NMPA official website

According to public information, gilteritinib is a drug discovered through collaborative research between Astellas and Kotobuki Pharmaceutical Co., Ltd. Astellas holds exclusive global rights for the development, manufacturing, and commercialization of gilteritinib. Previously, this product has been approved for marketing in the United States, Japan, and multiple European countries, and has received FDA Fast Track designation, Orphan Drug designation, and Priority Review designation.

Studies have shown that gilteritinib can inhibit two common FLT3 mutations found in approximately one-third of patients with acute myeloid leukemia (AML): FLT3-ITD and FLT3-TKD. It is reported to sustain inhibition of FLT3 activity in vivo and is less likely to cause myelosuppression. Furthermore, it inhibits the receptor tyrosine kinase AXL, thereby blocking a potential mechanism by which tumor cells develop resistance.

In China, Astellas submitted a new drug application for gilteritinib in April 2020, which was accepted and subsequently included in the priority review as a “drug eligible for conditional approval.” The drug is intended for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) harboring FLT3 mutations.

Screenshot source: CDE official website

Notably, in November 2020, the Center for Drug Evaluation (CDE) released the third batch of the List of Overseas New Drugs in Urgent Clinical Need. Astellas’ gilteritinib was included on this list on the grounds that it addresses an urgent clinical need, demonstrates significant clinical advantages, and is indicated for patients with refractory or relapsed disease. Its inclusion in the Priority Review Program and the List of Overseas New Drugs in Urgent Clinical Need has, to some extent, accelerated the review and approval process for gilteritinib in China, bringing this innovative therapy closer to Chinese patients with leukemia.

In the United States, the FDA approved gilteritinib for marketing in November 2018 for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) harboring FLT3 gene mutations. The presence of these mutations must be confirmed by an FDA-approved companion diagnostic. According to a previously issued FDA press release, it is the first drug approved as monotherapy for patients with FLT3-mutated AML who have relapsed or are refractory to initial treatment.

Acute Myeloid Leukemia (AML) is a rapidly progressing hematologic malignancy. The continuous proliferation and accumulation of leukemic cells impair the production of normal blood cells, necessitating regular blood transfusions for patients. Data indicate that AML ranks sixth in incidence among all cancers worldwide.

It is reported that approximately 25% to 30% of patients with acute myeloid leukemia (AML) harbor FLT3 gene mutations, which are associated with a particularly aggressive form of the disease and a higher risk of relapse. Patients with FLT3-mutation-positive AML have a very poor prognosis, with a median survival of less than 6 months following salvage chemotherapy. During the course of AML treatment, and even after relapse, the FLT3 mutation status may change. Therefore, confirming the patient’s FLT3 mutation status helps determine the optimal treatment approach.

Clinical study results demonstrate that gilteritinib significantly prolongs overall survival and improves survival rates in patients with relapsed or refractory acute myeloid leukemia (AML) harboring FLT3 mutations. Congratulations to Astellas on the approval of gilteritinib for marketing in China. Its availability will bring new treatment options and hope to Chinese patients with relapsed or refractory AML.

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