Astellas Announces Acceptance of XOSPATA® (gilteritinib) for Regulatory Review in China by the National Medical Products Administration

TOKYO, April 9, 2020 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") announced today a new drug application (NDA) for the oral once-daily therapy XOSPATA® (gilteritinib), for the treatment of adult patients who have relapsed (disease that has returned) or refractory (resistant to treatment) acute myeloid leukemia (AML) with a FLT3 mutation (FLT3mut+), has been accepted by the National Medical Products Administration (NMPA) for regulatory review in China.

AML is a cancer that impacts the blood and bone marrow,1 and its incidence increases with age.2 It is estimated that every year, around 80,000 people in China are diagnosed with leukemia.3 AML is one of the most common types of leukemia in adults.4

AML patients with a FLT3 mutation have a particularly poor prognosis, with a median survival of less than six months following treatment with salvage chemotherapy.5 The status of FLT3 mutation can change over the course of AML treatment, even after relapse. As such, a patient's mutation status should be determined to help inform the best treatment approach.6

About Gilteritinib
Gilteritinib was discovered through a research collaboration with Kotobuki Pharmaceutical Co., Ltd., and Astellas has exclusive global rights to develop, manufacture and commercialize gilteritinib. Gilteritinib was approved in the U.S. and Japan in 2018, Europe and Canada in 2019, and Korea, Brazil and Australia thus far in 2020 for the treatment of adult patients who have relapsed or refractory FLT3mut+ AML.7,8,9,10,11,12,13 As of April 2020, gilteritinib is available in the U.S., Japan and selected countries in Europe.

Gilteritinib is a FMS-like tyrosine kinase 3 (FLT3) and has demonstrated inhibitory activity against FLT3-ITD, a type of FLT3mut+ that is seen in approximately one-third of patients with AML, as well as FLT3-TKD mutation. FLT3-ITD is a common driver mutation that presents with a high burden and poor prognosis.14

About Astellas
Astellas Pharma Inc., based in Tokyo, Japan, is a company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. For more information, please visit our website at

Astellas Cautionary Notes
In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties.

Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice.


1 American Cancer Society. What is Acute Myeloid Leukemia (AML)? Available at Last accessed March 2020.
2 American Cancer Society. Risk Factors for Acute Myeloid Leukemia (AML). Available at: Last accessed February 2020.
3 GLOBOCAN Cancer Today Database, International Agency for Research on Cancer, World Health Organisation. Population Fact Sheets in 2018. Available at: Last accessed March 2020.
4 American Cancer Society. Key Statistics for Acute Myeloid Leukemia (AML). Available at Last accessed March 2020.
5 Perl, A et al. Gilteritinib significantly prolongs overall survival in patients with FLT3-mutated (FLT3mut+) relapsed/refractory (R/R) acute myeloid leukemia (AML): Results from the Phase III ADMIRAL trial. Presented as abstract CT184 at the AACR Annual Meeting, April 2 2019.
6 Warren M, et al. Clinical impact of change of FLT3 mutation status in acute myeloid leukemia patients. Mod Pathol. 2012;25(10):1405-12
7 US Food and Drug Administration. FDA approves treatment for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a certain genetic mutation. Available at: Last accessed August 2019.
8 Japan Pharmaceutical and Medical Devices Agency (PMDA). New Drug approvals, April 2018 - March 2019. Available at: Last accessed September 2019.
9 European Medicines Agency. Authorization of medicines. Available at: Last accessed October 2019.
10 Astellas. Health Canada approves Astellas' XOSPATA® (gilteritinib) for patients with relapsed or refractory acute myeloid leukemia with a FLT3 mutation. Available at Last accessed March 2020.
11 Korea Biomedical Review. Astellas' Xospata wins license for acute myeloid leukemia. Available at Last accessed March 2020.
12 GBI Source. Astellas' cancer drug Xospata bags first Latin American approval in Brazil. Available at 3a 2f 2fNews 2fNewsDetail 3fnewsID 3d2034094 26newsType dnews. Last accessed April 2020.
13 Data on file. Northbrook, IL. Astellas Pharma, Inc.
14 Daver N, Schlenk RF, Russel NH, Levis MJ. (2019). Targeting FLt3 mutations in AML: review of current knowledge and evidence. Leukemia 33: 299-312.

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Company Codes: Tokyo:4503, OTC-PINK:ALPMY

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