Gilteritinib Fumarate Tablets Included in China's List of Clinically Urgent Overseas New Drugs for AML Treatment

Beijing, November 23, 2020 – Astellas announced that XOSPATA® (generic name in English: gilteritinib fumarate tablets; generic name in Chinese: gilteritinib fumarate tablets, hereinafter collectively referred to as gilteritinib), indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) harboring FLT3 mutations, has been officially included in the third batch of the List of Overseas New Drugs in Urgent Clinical Need by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration. This marks another milestone for gilteritinib fumarate tablets following the inclusion of its new drug marketing authorization application in the priority review program in July this year.

Acute Myeloid Leukemia (AML) is a malignancy affecting the blood and bone marrow, with incidence increasing with age. AML is one of the most common types of leukemia in adults. Statistics indicate that approximately 80,000 people are diagnosed with leukemia annually in China. Over the past decade, progress in the treatment of relapsed/refractory acute myeloid leukemia has been slow; patients face short survival times and numerous complications, and therapeutic options remain very limited beyond salvage chemotherapy and hematopoietic stem cell transplantation.

Hiroshi Hamaguchi, Chairman and General Manager of Astellas Pharma (China) Co., Ltd., stated, “We are greatly encouraged by the inclusion of gilteritinib in the priority review program and on the list of urgently needed overseas new drugs. We deeply appreciate that the continuous optimization of China’s drug evaluation and approval system has significantly accelerated the introduction of new medicines. Currently, there remains an unmet medical need in the treatment of acute myeloid leukemia (AML). Astellas is committed to translating innovative science into value for patients, and we look forward to bringing this breakthrough therapeutic option to AML patients in China as soon as possible.”

Rodney Long, Head of Astellas China’s Oncology Business Unit, stated, “Gilteritinib is Astellas’ first hematologic oncology drug. Studies have shown that patients with FLT3-mutation-positive acute myeloid leukemia (AML) have a poor prognosis, with a median survival of less than six months after chemotherapy. The advent of gilteritinib will break this status quo. Its inclusion on the List of Urgently Needed Overseas New Drugs for Clinical Use is expected to bring new treatment options to doctors and patients in China more rapidly, offering new hope to patients and their families.”

Gilteritinib has achieved patient accessibility in the United States, Japan, select European Union countries, and other regions. On March 24, 2020, a marketing application for gilteritinib was submitted in China, and it was granted priority review status on July 21. Its inclusion in the List of Overseas New Drugs Urgently Needed for Clinical Use will pave an accelerated pathway for the approval and market launch of gilteritinib in China.

About Gilteritinib

Gilteritinib is a drug discovered through a research collaboration between Astellas and Kotobuki Pharmaceutical Co., Ltd. Astellas holds exclusive global rights to develop, manufacture, and commercialize gilteritinib. Gilteritinib has become accessible to patients in the United States, Japan, select countries in the European Union, and other regions and countries for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) harboring FLT3 mutations.

Gilteritinib is a FMS-like tyrosine kinase 3 (FLT3) inhibitor that exhibits significant inhibitory activity against FLT3-ITD. FLT3-ITD is a common driver mutation associated with high disease burden and poor prognosis, as well as FLT3-TKD mutations.

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