TOKYO, Dec. 10, 2018 /PRNewswire/ -- 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.1 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.
About Acute Myeloid Leukemia
Acute Myeloid Leukemia (AML) is a cancer that impacts the blood and bone marrow,2 and its incidence
increases with age.3 The American Cancer Society estimates that in 2018, approximately 19,000 people will be diagnosed
with AML in the U.S.3
About XOSPATA (gilteritinib)
XOSPATA is indicated for the treatment of adult patients who have relapsed or refractory Acute Myeloid Leukemia (AML)
with a FMS-like tyrosine kinase 3 (FLT3) mutation as detected by an FDA-approved test.1 XOSPATA is also approved
by the Japan Ministry of Health, Labor and Welfare (MHLW) for relapsed or refractory AML with FLT3 mutations. It is launched
as XOSPATA® 40 mg Tablets in Japan.
Gilteritinib was discovered through a research collaboration with Kotobuki Pharmaceutical Co., Ltd., and Astellas has
exclusive global rights to develop, manufacture and commercialize gilteritinib.
Astellas is currently investigating gilteritinib in various FLT3 mutation-positive AML patient populations through several
Phase 3 trials. Visit AstellasAMLTrials.com to
learn more about ongoing gilteritinib clinical trials.
Important Safety Information
Contraindications
XOSPATA is contraindicated in patients with hypersensitivity to gilteritinib or any of the excipients. Anaphylactic
reactions have been observed in clinical trials.
Warnings and Precautions
Posterior Reversible Encephalopathy Syndrome (PRES) There have been rare reports of PRES with symptoms including
seizure and altered mental status with XOSPATA. Symptoms have resolved after discontinuation of XOSPATA. A diagnosis of PRES
requires confirmation by brain imaging, preferably MRI. Discontinue XOSPATA in patients who develop PRES.
Prolonged QT Interval XOSPATA has been associated with prolonged cardiac ventricular repolarization (QT interval). Of
the 292 patients treated with XOSPATA in the clinical trial, 1.4% were found to have a QTc interval greater than 500 msec and 7%
of patients had an increase from baseline QTc greater than 60 msec. Perform electrocardiogram (ECG) prior to initiation of
treatment with XOSPATA, on days 8 and 15 of cycle 1, and prior to the start of the next two subsequent cycles. Interrupt and
reduce XOSPATA dosage in patients who have a QTcF >500 msec. Hypokalemia or hypomagnesemia may increase the QT prolongation
risk. Correct hypokalemia or hypomagnesemia prior to and during XOSPATA administration.
Pancreatitis There have been rare reports of pancreatitis in patients receiving XOSPATA in clinical studies. Evaluate
patients who develop signs and symptoms of pancreatitis. Interrupt and reduce the dose of XOSPATA in patients who develop
pancreatitis.
Embryo-Fetal Toxicity Based on findings in animals and its mechanism of action, XOSPATA can cause embryo-fetal harm
when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment
with XOSPATA and for at least 6 months after the last dose of XOSPATA. Advise males with female partners of reproductive
potential to use effective contraception during treatment with XOSPATA and for at least 4 months after the last dose of XOSPATA.
Pregnant women, patients becoming pregnant while receiving XOSPATA or male patients with pregnant female partners should be
apprised of the potential risk to the fetus.
Adverse Reactions
The most frequent non-hematological serious adverse reactions (?5%) reported in patients were pneumonia (19%), sepsis
(13%), fever (13%), dyspnea (7%) and renal impairment (5%).
Overall, 22 of 292 patients (8%) discontinued XOSPATA treatment permanently due to an adverse reaction. The most common
adverse reactions (>1%) leading to discontinuation were pneumonia (2%), sepsis (2%) and dyspnea (1%). The most common adverse
reactions (?20%) were myalgia/arthralgia (42%), transaminase increased (41%), fatigue/malaise (40%), fever (35%), non-infectious
diarrhea (34%), dyspnea (34%), edema (34%), rash (30%), pneumonia (30%), nausea (27%), stomatitis (26%), cough (25%), headache
(21%), hypotension (21%), dizziness (20%) and vomiting (20%).
Other clinically significant adverse reactions occurring in ?10% of patients included: electrocardiogram QT prolonged (7%),
cardiac failure (grouped terms) (4%), pericardial effusion (3%), pericarditis (2%), differentiation syndrome (1%), anaphylactic
reaction (1%) and posterior reversible encephalopathy syndrome (1%).
Lab Abnormalities: The most common lab abnormalities (>20%) that were Grade ?3 that occurred ?10% were:
hypophosphatemia (12%), alanine aminotransferase increased (12%), hyponatremia (12%), aspartate aminotransferase increased
(10%).
Drug Interactions
Combined P-gp and Strong CYP3A Inducers: Concomitant use of XOSPATA with a combined P-gp and strong CYP3A
inducer decreases XOSPATA exposure which may decrease XOSPATA efficacy. Avoid concomitant use of XOSPATA with combined P-gp and
strong CYP3A inducers.
Strong CYP3A inhibitors: Concomitant use of XOSPATA with a strong CYP3A inhibitor increases XOSPATA exposure.
Consider alternative therapies that are not strong CYP3A inhibitors. If the concomitant use of these inhibitors is considered
essential for the care of the patient, monitor patient more frequently for XOSPATA adverse reactions. Interrupt and reduce
XOSPATA dosage in patients with serious or life-threatening toxicity.
Drugs that Target 5HT2B Receptor or Sigma Nonspecific Receptor: Concomitant use of XOSPATA may reduce the effects
of drugs that target the 5HT2B receptor or the sigma nonspecific receptor (e.g., escitalopram, fluoxetine, sertraline). Avoid
concomitant use of these drugs with XOSPATA unless their use is considered essential for the care of the patient.
Specific Populations
Lactation: Advise women not to breastfeed during treatment with XOSPATA and for 2 months after the last
dose.
Please see Full
Prescribing Information for additional safety information.
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 https://www.astellas.com/en/
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.
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1 XOSPATA [package insert]. Northbrook, IL: Astellas Pharma US, Inc.
2 American Cancer Society. What is acute myeloid leukemia? (02-22-2016). https://www.cancer.org/cancer/acute-myeloid-leukemia/about/what-is-aml.html. Accessed 05-10-2018.
3 American Cancer Society. Key statistics for acute myeloid leukemia (01-04-2018). https://www.cancer.org/cancer/acute-myeloid-leukemia/about/key-statistics.html. Accessed 03-12-2018.
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