Astellas Launches XOSPATA® (gilteritinib) in the U.S. for the Treatment of Adult Patients with Relapsed/Refractory Acute Myeloid Leukemia (AML) with a FLT3 Mutation

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Astellas Launches XOSPATA® (gilteritinib) in the U.S. for the Treatment of Adult Patients with Relapsed/Refractory Acute Myeloid Leukemia (AML) with a FLT3 Mutation

PR Newswire

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.

(PRNewsfoto/Astellas Pharma Inc.)

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.

_____________________________
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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SOURCE Astellas Pharma Inc.

Awakening to Love Press Releases Its First Book Entitled Relationship Chronicles: The Truth About the Stories We Tell Ourselves

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Awakening to Love Press Releases Its First Book Entitled Relationship Chronicles: The Truth About the Stories We Tell Ourselves

Go from a relationship victim to a relationship rock star with this debut from author James A. Valentine

PR Newswire

DOVER, Del., Dec. 10, 2018 /PRNewswire/ — A page-turning debut in the tradition of Osho’s ”Being In Love” and the spiritual teachings of Eckhart Tolle and Byron Katie, “Relationship Chronicles” is a dynamic self-help, personal development book, and Amazon best-seller from spiritual teacher James A. Valentine that will take his readers behind the veil to one of life’s greatest struggles – relationships. This book will challenge his readers to contemplate everything they have ever believed about love and relationships and give them the tools to transform it into a powerful force in their life. 

In this book, author, speaker, and spiritual life coach James Valentine chronicles the journey his readers take from longing for love to finding the love of their lives, and then after disappointment, finding themselves right back where they started. He will expose the stories they tell themselves about why it didn’t work and why they couldn’t find lasting love and introduce the hard truths along each path of the journey to once and for all open his readers up to true, enduring, and authentic love. 

James A. Valentine, the father of a beautiful daughter, Savannah, has been working as an author, minister, spiritual life coach, speaker, and teacher for over 25 years. 

After entering the darkest period of his life, James was able to identify and overcome roadblocks, pain, and struggles that he had lived with unconsciously for most of his life. Through his journey of self-discovery and self-love, he learned and implemented certain techniques in his life that allowed him to see almost instant positive results, letting go of unhealthy relationships, self-sabotaging thoughts, and more.

This book will challenge and redefine every relationship in life for the better.

Available now in Print & EBook online from Amazon, Barnes & Noble, Smashwords, BookBub, Goodreads, and in partnership with publisher ATL Publishing.

Contact: Awakening To Love Publishing
Tel. (302) 308-1638
Email: jvalentine1043@awakeningtolove.org

Related Links

Website

Facebook Page

 

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SOURCE Awakening To Love Press

LG to Unveil Capsule-Based Craft Beer System at CES 2019

LG to Unveil Capsule-Based Craft Beer System at CES 2019

Canada NewsWire

Automated Process and Exclusive Technologies

Deliver Total DIY Solution for Beer Enthusiasts

TORONTO, Dec. 10, 2018 /CNW/ – LG Electronics (LG) will debut a capsule-based craft beer making machine, LG HomeBrew, at CES 2019. A winner of a 2019 CES Innovation Award, the state-of-the-art device makes the brewing process incredibly easy thanks to its single-use capsules, optimized fermentation algorithm and convenient self-cleaning feature, the ideal product for anyone seeking the satisfaction of creating their own cold, tasty beer.

LG Electronics (LG) will debut a capsule-based craft beer making machine, LG HomeBrew, at CES 2019 – a winner of a 2019 CES Innovation Award. (CNW Group/LG Electronics, Inc.)

LG’s unique capsule-based system brings revolutionary simplicity to the art of brewing with one-touch activation. With a set of single-use capsules – which contain malt, yeast, hop oil and flavoring – and the press of a button, users can relax as LG HomeBrew automates the whole procedure from fermentation, carbonation and aging to serving and cleaning. A free companion app (for Android and iOS devices) lets users check HomeBrew’s status at any time, anywhere.

HomeBrew not only offers an incredibly simple way to make craft beer, it also enhances the quality of beer it makes. An optimized fermentation algorithm intelligently controls the fermenting process with precise temperature and pressure control for guaranteed brewing success. The clever capsule system also removes all the cleaning-related frustrations associated with traditional home-brewing methods. It automatically sanitizes using nothing more than hot water, ensuring everything is hygienically clean for the next batch.

Designed with discerning beer lovers in mind, HomeBrew allows for the in-home production of various popular styles insuring excellent results with every batch. Five distinctive, richly-flavored beers are sure to impress: hoppy American IPA, golden American Pale Ale, full-bodied English Stout, zesty Belgian-style Witbier and dry Czech Pilsner. It can produce up to five litres of premium quality beer in approximately two weeks depending on the beer type.

“LG HomeBrew is the culmination of years of home appliance and water purification technologies that we have developed over the decades,” said Song Dae-hyun, president of LG Electronics Home Appliance & Air Solution Company. “Homebrewing has grown at an explosive pace but there are still many beer lovers who haven’t taken the jump because of the barrier to entry and these are the consumers we think will be attracted to LG HomeBrew.”

Visitors to CES 2019 from January 8-11 will be able to experience LG’s revolutionary HomeBrew at booth #11100 in the Las Vegas Convention Center.

About LG Electronics Home Appliance & Air Solutions

LG Electronics is a global leader in home appliances, air conditioning and air quality systems. The company is creating total solutions for the home with its industry leading core technologies. LG is committed to making life better for consumers around the world by providing thoughtfully designed products, including refrigerators, washing machines, dishwashers, cooking appliances, vacuum cleaners, built-in appliances, air conditioners, air purifiers and dehumidifiers. Collectively, these products deliver enhanced convenience, superb performance, great savings and compelling health benefits. For more information, please visit www.LG.com.  

About LG Electronics Canada Inc.

The LG brand was established in 1995. The company is a global leader in electronics, information and communications products, with more than 117 operations around the world, and annual worldwide revenues of more than US $49 billion. LG Electronics Canada Inc. is comprised of five business units – Mobile Communications, Home Appliance, Home Entertainment, Business Solutions and Commercial Air Conditioning. The company has offices in Toronto and Vancouver. LG Electronics Canada Inc. is focused on delivering award-winning products known for blending style and technology. These innovative products include cell phones, flat screen TVs, laptop computers and home appliances. For more information please visit http://www.lg.com/ca_en.

Designed with discerning beer lovers in mind, LG HomeBrew allows for the in-home production of various popular styles insuring excellent results with every batch. (CNW Group/LG Electronics, Inc.)

SOURCE LG Electronics, Inc.

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