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NEW YORK and TOKYO, Dec. 16, 2019 /PRNewswire/ — Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) appear today that the U.S. Food and Biologic Administration (FDA) has accustomed a added New Biologic Application (sNDA) for XTANDI® (enzalutamide) for the assay of patients with metastatic castration-sensitive prostate blight (mCSPC). In 2019, it is estimated that aloof over 40,000 men in the United States are active with mCSPC, a anatomy of prostate blight that has advance to added genitalia of the anatomy and still responds to a medical or surgical assay that lowers testosterone.1,2,3



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With this approval, XTANDI is now the aboriginal and alone articulate assay accustomed by the FDA in three audible types of avant-garde prostate blight – non-metastatic and metastatic castration-resistant prostate blight (CRPC) and mCSPC. The approval is based on after-effects from ARCHES, a randomized Phase 3 abstraction which evaluated 1,150 men with mCSPC and met its primary endpoint of radiographic progression-free adaptation (rPFS).

“Men with metastatic castration-sensitive prostate blight face circuitous assay decisions and it is analytical for physicians and patients to accept as abundant admonition as accessible aback chief on all of the options available,” said Andrew Armstrong, M.D., Professor of Medicine, Surgery, Pharmacology and Blight Biology, Director of Assay in the Duke Blight Institute’s Center for Prostate and Urologic Cancers and advance investigator of ARCHES. “The assay acknowledging the FDA approval and adapted assay guidelines accommodate physicians and patients with acute affirmation to accede enzalutamide as a assay advantage for men with this disease.”



Data from the ARCHES balloon accustomed that the use of XTANDI added androgen denial assay (ADT) decidedly bargain the blow of radiographic progression or afterlife by 61 percent compared to placebo added ADT (n=1,150; hazard arrangement [HR]: 0.39 [95% aplomb breach (CI): 0.30-0.50]; p<0.0001). Overall adaptation abstracts were not complete at the time of final rPFS analysis.

The assurance assay of the ARCHES balloon is about constant with the assurance contour of XTANDI in antecedent analytic trials in CRPC. In ARCHES, accustomed adverse reactions (Grade 1 to 4 ARs; occurring in at atomic 5% of patients) that were appear added frequently in patients advised with XTANDI added ADT vs placebo added ADT included hot even (27% vs 22%), asthenic altitude (24% vs 20%), hypertension (8.0% vs 5.6%), fractures (6.5% vs 4.2%), and musculoskeletal affliction (6.3% vs 4.0%).  



“XTANDI has been accustomed as a accustomed of affliction for men with castration-resistant prostate blight and has been assigned to added than 420,000 patients accustomed aback it was aboriginal accustomed in 2012,” said Andrew Krivoshik, M.D., Ph.D., Senior Vice President and Oncology Ameliorative Area Arch at Astellas. “This approval in metastatic castration-sensitive prostate blight agency physicians can now action XTANDI to men beforehand in their avant-garde prostate blight assay journey.”

“Today’s approval adds to over a decade of all-around analytic assay aimed at bigger compassionate the abeyant account of XTANDI for men with avant-garde prostate cancer,” said Andy Schmeltz, All-around President, Pfizer Oncology. “The FDA approval marks connected advance to admonition accommodated the needs of patients, including men active with metastatic castration-sensitive prostate cancer.” 

Pfizer and Astellas are committed to allowance patients admission XTANDI by accouterment them with admission and acceding abutment resources, including admonition apropos accommodating healthcare advantage options and banking abetment options that may be accessible to admonition patients with banking needs. Patients can appointment www.XTANDI.com or alarm XTANDI Abutment Solutions at 1-855-898-2634 to apprentice more.

About Metastatic Castration-Sensitive Prostate CancerProstate blight is advised metastatic already it has advance alfresco of the prostate gland to added genitalia of the body, such as the bones, lymph nodes, bladder, and rectum.2 Men are advised castration- (or hormone-) acute if their ache still responds to medical or surgical assay to lower testosterone levels.1 The prevalence of mCSPC in the U.S. in 2019 is estimated to be aloof over 40,000.3

ARCHES Balloon The company-sponsored, Phase 3, randomized, double-blind, placebo-controlled, multi-national ARCHES balloon (NCT02677896) enrolled 1,150 patients with mCSPC at sites in the U.S., Canada, Europe, South America, and the Asia-Pacific region. Patients in the balloon were randomized to accept XTANDI 160 mg circadian or placebo and connected on a luteinizing hormone-releasing hormone (LHRH) agonist or adversary or had a history of mutual orchiectomy.

The primary endpoint of the balloon was rPFS adjourned by addled absolute axial review. Radiographic progression-free adaptation was authentic as the time from randomization to radiographic ache progression at any time or afterlife aural 24 weeks afterwards abstraction biologic discontinuation. Radiographic ache progression was authentic by identification of two or added new cartilage lesions on a cartilage browse with acceptance (Prostate Blight Working Group 2 criteria) and/or progression in bendable tissue disease. Patients were stratified by aggregate of ache (low vs high) and above-mentioned docetaxel assay for prostate blight (no above-mentioned docetaxel, 1-5 cycles, or 6 above-mentioned cycles).

About XTANDI® (enzalutamide) XTANDI (enzalutamide) is an androgen receptor inhibitor adumbrated for the assay of patients with castration-resistant prostate blight (CRPC) and metastatic castration-sensitive prostate blight (mCSPC).

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Important Assurance Admonition for XTANDI®

Warnings and Precautions

Seizure occurred in 0.5% of patients accepting XTANDI in seven randomized analytic trials. In a abstraction of patients with predisposing factors for seizure, 2.2% of XTANDI-treated patients accomplished a seizure. It is alien whether anti-epileptic medications will anticipate seizures with XTANDI. Patients in the abstraction had one or added of the afterward predisposing factors: use of medications that may lower the access threshold, history of alarming academician or arch injury, history of cerebrovascular blow or brief ischemic attack, and Alzheimer’s disease, meningioma, or leptomeningeal ache from prostate cancer, alien accident of alertness aural the aftermost 12 months, history of seizure, attendance of a amplitude application bane of the brain, history of arteriovenous malformation, or history of academician infection. Advise patients of the blow of developing a access while demography XTANDI and of agreeable in any action area abrupt accident of alertness could account austere abuse to themselves or others. Permanently abandon XTANDI in patients who advance a access during treatment.

Posterior Reversible Encephalopathy Syndrome (PRES) There accept been letters of PRES in patients accepting XTANDI. PRES is a acoustic ataxia that can present with rapidly evolving affection including seizure, headache, lethargy, confusion, blindness, and added beheld and acoustic disturbances, with or afterwards associated hypertension. A analysis of PRES requires acceptance by academician imaging, finer MRI. Abandon XTANDI in patients who advance PRES.

Hypersensitivity reactions, including edema of the face (0.5%), argot (0.1%), or lip (0.1%) accept been empiric with XTANDI in seven randomized analytic trials. Pharyngeal edema has been appear in post-marketing cases. Advise patients who acquaintance any affection of hypersensitivity to briefly abandon XTANDI and promptly seek medical care. Permanently abandon XTANDI for austere hypersensitivity reactions.

Ischemic Affection Disease  In the accumulated abstracts of four randomized, placebo-controlled analytic studies, ischemic affection ache occurred added frequently in patients on the XTANDI arm compared to patients on the placebo arm (2.9% vs 1.3%). Grade 3-4 ischemic contest occurred in 1.4% of patients on XTANDI against 0.7% on placebo. Ischemic contest led to afterlife in 0.4% of patients on XTANDI compared to 0.1% on placebo. Monitor for signs and affection of ischemic affection disease. Optimize administration of cardiovascular blow factors, such as hypertension, diabetes, or dyslipidemia. Abandon XTANDI for Grade 3-4 ischemic affection disease.

Falls and Fractures occurred in patients accepting XTANDI. Evaluate patients for breach and abatement risk. Monitor and administer patients at blow for fractures according to accustomed assay guidelines and accede use of bone-targeted agents. In the accumulated abstracts of four randomized, placebo-controlled analytic studies, avalanche occurred in 11% of patients advised with XTANDI compared to 4% of patients advised with placebo. Fractures occurred in 10% of patients advised with XTANDI and in 4% of patients advised with placebo.

Embryo-Fetal Toxicity The assurance and adeptness of XTANDI accept not been accustomed in females. XTANDI can account fetal abuse and accident of abundance aback administered to a abundant female. Advise males with changeable ally of changeable abeyant to use able contraception during assay with XTANDI and for 3 months afterwards the aftermost dosage of XTANDI.

Adverse Reactions (ARs)In the abstracts from the four randomized placebo-controlled trials, the best accustomed ARs (≥ 10%) that occurred added frequently (≥ 2% over placebo) in XTANDI-treated patients were asthenia/fatigue, aback pain, hot flush, constipation, arthralgia, decreased appetite, diarrhea, and hypertension. In the bicalutamide-controlled study, the best accustomed ARs (≥ 10%) appear in XTANDI-treated patients were asthenia/fatigue, aback pain, musculoskeletal pain, hot flush, hypertension, nausea, constipation, diarrhea, high respiratory amplitude infection, and weight loss. 

In AFFIRM, the placebo-controlled abstraction of metastatic CRPC (mCRPC) patients who ahead accustomed docetaxel, Grade 3 and college ARs were appear amid 47% of XTANDI-treated patients. Discontinuations due to adverse contest (AEs) were appear for 16% of XTANDI-treated patients. In PREVAIL, the placebo-controlled abstraction of chemotherapy-naive mCRPC patients, Grade 3-4 ARs were appear in 44% of XTANDI patients and 37% of placebo patients. Discontinuations due to AEs were appear for 6% of XTANDI-treated patients. In TERRAIN, the bicalutamide-controlled abstraction of chemotherapy-naive mCRPC patients, Grade 3-4 ARs were appear in 39% of XTANDI patients and 38% of bicalutamide patients. Discontinuations with an AE as the primary acumen were appear for 8% of XTANDI patients and 6% of bicalutamide patients. 

In PROSPER, the placebo-controlled abstraction of non-metastatic CRPC (nmCRPC) patients, Grade 3 or college ARs were appear in 31% of XTANDI patients and 23% of placebo patients. Discontinuations with an AE as the primary acumen were appear for 9% of XTANDI patients and 6% of placebo patients.

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In ARCHES, the placebo-controlled abstraction of metastatic CSPC (mCSPC) patients, Grade 3 or college AEs were appear in 24% of XTANDI-treated patients. Permanent cessation due to AEs as the primary acumen was appear in 5% of XTANDI patients and 4% of placebo patients.

Lab Abnormalities: Lab abnormalities that occurred in ≥ 5% of patients, and added frequently (> 2%) in the XTANDI arm compared to placebo in the pooled, randomized, placebo-controlled studies are neutrophil calculation decreased, white claret corpuscle decreased, hyperglycemia, hypermagnesemia, hyponatremia, and hypercalcemia.

Hypertension:  In the accumulated abstracts from four randomized placebo-controlled analytic trials, hypertension was appear in 12% of XTANDI patients and 5% of placebo patients. Hypertension led to abstraction cessation in < 1% of patients in anniversary arm.

Drug Interactions

Effect of Added Drugs on XTANDI Avoid able CYP2C8 inhibitors, as they can access the claret acknowledgment to XTANDI. If co-administration is necessary, abate the dosage of XTANDI.

Avoid able CYP3A4 inducers as they can abatement the claret acknowledgment to XTANDI. If co-administration is necessary, access the dosage of XTANDI.

Effect of XTANDI on Added Drugs Avoid CYP3A4, CYP2C9, and CYP2C19 substrates with a attenuated ameliorative index, as XTANDI may abatement the claret exposures of these drugs. If XTANDI is co-administered with warfarin (CYP2C9 substrate), conduct added INR monitoring.

Please see Full Prescribing Information for added assurance information. 

About the Enzalutamide Development ProgramAs allotment of Pfizer and Astellas’ advancing charge to the analytic development of enzalutamide, XTANDI is additionally actuality evaluated in the EMBARK trial, in men with high-risk non-metastatic CSPC. Details about EMBARK (NCT02319837) are accessible on www.clinicaltrials.gov.

The European Medicines Agency (EMA) and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan are currently evaluating XTANDI for men with metastatic hormone-sensitive prostate cancer.

About Astellas Astellas Pharma Inc., based in Tokyo, Japan, is a aggregation committed to convalescent the bloom of bodies about the apple through the accouterment of avant-garde and reliable biologic products. For added information, amuse appointment our website at https://www.astellas.com/en.  

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About Pfizer OncologyAt Pfizer Oncology, we are committed to advancing medicines wherever we accept we can accomplish a allusive aberration in the lives of patients. Today, Pfizer Oncology has an industry-leading portfolio of 22 accustomed avant-garde blight medicines and biosimilars beyond added than 30 indications, including breast, prostate, branch and lung cancers, as able-bodied as leukemia and melanoma. Pfizer Oncology is appetite to change the aisle of cancer.

About the Pfizer/Astellas Collaboration In October 2009, Medivation, Inc., which is now allotment of Pfizer (NYSE: PFE), and Astellas (TSE: 4503) entered into a all-around acceding to accordingly advance and commercialize enzalutamide. The companies accordingly commercialize XTANDI in the United States and Astellas has albatross for accomplishment and all added authoritative filings globally, as able-bodied as commercializing XTANDI alfresco the United States.

Astellas Forward-Looking Statement In this columnist release, statements fabricated with account to accustomed plans, estimates, strategies and behavior and added statements that are not absolute facts are advanced statements about the approaching achievement of Astellas. These statements are based on management’s accustomed assumptions and behavior in ablaze of the admonition currently accessible to it and absorb accustomed and alien risks and uncertainties. A cardinal of factors could account absolute after-effects to alter materially from those discussed in the advanced statements. Such factors include, but are not bound to: (i) changes in accustomed bread-and-butter altitude and in laws and regulations, apropos to biologic markets, (ii) bill barter amount fluctuations, (iii) delays in new artefact launches, (iv) the disability of Astellas to bazaar absolute and new articles effectively, (v) the disability of Astellas to abide to finer assay and advance articles accustomed by barter in awful aggressive markets, and (vi) infringements of Astellas’ bookish acreage rights by third parties.

Information about biologic articles (including articles currently in development), which is included in this columnist absolution is not advised to aggregate an advertisement or medical advice.

Pfizer Disclosure NoticeThe admonition independent in this absolution is as of December 16, 2019. Pfizer assumes no obligation to amend advanced statements independent in this absolution as the aftereffect of new admonition or approaching contest or developments.

This absolution contains advanced admonition about XTANDI® (enzalutamide) and a new adumbration in the U.S. for the assay of men with metastatic castration-sensitive prostate cancer, including their abeyant benefits, that involves abundant risks and uncertainties that could account absolute after-effects to alter materially from those bidding or adumbrated by such statements. Risks and uncertainties include, amid added things, uncertainties apropos the bartering success of XTANDI; the uncertainties inherent in assay and development, including the adeptness to accommodated advancing analytic endpoints, admission and/or achievement dates for our analytic trials, authoritative acquiescence dates, authoritative approval dates and/or barrage dates, as able-bodied as the achievability of abortive new analytic abstracts and added analyses of absolute analytic data; the blow that analytic balloon abstracts are accountable to differing interpretations and assessments by authoritative authorities; whether authoritative authorities will be annoyed with the architecture of and after-effects from our analytic studies; whether and aback biologic applications for the new adumbration for XTANDI may be filed in any added jurisdictions and whether and aback biologic applications for any added abeyant break for XTANDI may be filed in any jurisdictions; whether and aback authoritative authorities in any jurisdictions may accept any such added applications that may be awaiting or filed (including the applications beneath analysis by the EMA and PMDA in Japan for the new indication), which will depend on countless factors, including authoritative a assurance as to whether the product’s allowances outweigh its accustomed risks and assurance of the product’s adeptness and, if approved, whether XTANDI for any such abeyant new break will be commercially successful; decisions by authoritative authorities impacting labeling, accomplishment processes, assurance and/or added affairs that could affect the availability or bartering abeyant of XTANDI, including for the new indication; risks accompanying to accretion competitive, acceding and bread-and-butter challenges; assurance on the efforts and allotment by Astellas Pharma Inc. for the development, accomplishment and commercialization of XTANDI; and aggressive developments.

A added description of risks and uncertainties can be begin in Pfizer’s Annual Report on Anatomy 10-K for the budgetary year concluded December 31, 2018 and in its consecutive letters on Anatomy 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Admonition and Factors That May Affect Approaching Results”, as able-bodied as in its consecutive letters on Anatomy 8-K, all of which are filed with the U.S. Securities and Barter Commission and accessible at www.sec.gov and www.pfizer.com.

1Cancer.net. Prostate Cancer: Types of Assay (03-2018). https://www.cancer.net/cancer-types/prostate-cancer/types-treatment. Accessed 912-2019.2 American Society of Analytic Oncology. ASCO Answers: Prostate Blight (2018). http://www.cancer.net/sites/cancer.net/files/asco_answers_guide_prostate.pdf. Accessed 10-07-2019.3 Supplement to: Scher HI, Solo K, Valant J, Todd MB, Mehra M. Prevalence of prostate blight analytic states and bloodshed in the United States: estimates application a activating progression model. PLoS One 2015;10(10):e0139440.

SOURCE Astellas

https://www.astellas.com

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