Astellas Pharma : Presents New Data on XOSPATA in FLT3 Mutation-Positive Relapsed Refractory Acute Myeloid Leukemia at the 2019 American Society of Hematology Annual Meeting

TOKYO - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., 'Astellas') today announced the presentation of new data in acute myeloid leukemia (AML) at the 61st American Society of Hematology (ASH) Annual Meeting, taking place Dec. 7-10 in Orlando, Fla.

Seven abstracts sponsored by Astellas focus on patients with relapsed (disease that has returned) or refractory (resistant to treatment) AML with a FLT3 mutation (FLT3mut+). The abstracts include new findings from the Phase 3 ADMIRAL trial - an oral presentation on emerging mutations in patients who develop resistance after an initial response to XOSPATA and two poster presentations focused on patient-reported outcomes - as well as data on cost-effectiveness, FLT3 testing and treatment patterns, and venetoclax combination therapy.

'Astellas is committed to elevating care in hard-to-treat cancers, and since the approval of XOSPATA one year ago, we have continued expanding our research program to better understand and address unmet medical needs of patients with FLT3 mutation-positive AML,' said Andrew Krivoshik, M.D., Ph.D., Senior Vice President and Oncology Therapeutic Area Head, Astellas.

About XOSPATA (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 and in Europe in 2019 for the treatment of adult patients who have relapsed or refractory FLT3mut+ AML.123 As of December 2019 it is available in the US, Japan and several countries in Europe. In August 2019, gilteritinib was indicated as appropriate treatment for FLT3 mutation positive relapsed and refractory AML patients as Category 1 Recommendation from the National Comprehensive Cancer Network.4 In October 2019, results from the Phase 3 ADMIRAL trial were published in The New England Journal of Medicine.5

About XOSPATA (gilteritinib) in the United States

XOSPATA is indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with an FMS-like tyrosine kinase 3 (FLT3) mutation as detected by an FDA-approved test.6

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.

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.

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