TOKYO – December 11, 2018 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D. “Astellas”) today announced that XOSPATA® (generic name: gilteritinib) is now available for prescription in the United States for the treatment of adult patients who have relapsed or refractory (resistant to treatment) Acute Myeloid Leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.  An oral monotherapy, XOSPATA is the first and only FLT3-targeting agent approved by the FDA for the treatment of relapsed or refractory FLT3 mutation-positive (FLT3mut+) AML. 

XOSPATA was approved by the U.S. Food and Drug Administration (FDA) on November 28, 2018. Health professionals, patients and their caregivers can learn more about XOSPATA and support services provided through Astellas at https://www.xospata.com/.

“Astellas aims to pursue cutting-edge science that provides value to patients,” said Mark Reisenauer, senior vice president, oncology business unit, Astellas. “XOSPATA is an excellent example of how we are continuing to advance on this promise to patients.”

Astellas is providing a full range of patient support services for XOSPATA in the U.S. XOSPATA Support SolutionsSM offers access and reimbursement support to help patients access XOSPATA as prescribed by their healthcare providers . XOSPATA Support SolutionsSM also provides information regarding patient healthcare coverage options and financial assistance programs that may be available to help eligible patients with financial needs. Patients, caregivers and healthcare providers can visit www.xospatasupportsolutions.com or call 844-632-9272 to learn more.

Astellas reflected the impact from this launch in its financial forecasts of the current fiscal year ending March 31, 2019.