NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today appear that the U.S. Aliment and Biologic Administration (FDA) has accustomed VIZIMPRO® [vih-ZIM-pro] (dacomitinib), a kinase inhibitor for the first-line analysis of patients with metastatic non-small corpuscle lung blight (NSCLC) with epidermal beforehand agency receptor (EGFR) exon 19 abatement or exon 21 L858R barter mutations as detected by an FDA-approved test.
“Improving outcomes for patients is the axial focus of why we beforehand and bear new medicines. VIZIMPRO is yet accession archetype of Pfizer’s charge to accouterment added options in lung blight area there is abundant unmet need,” said Andy Schmeltz, All-around President, Pfizer Oncology. “With today’s approval, Pfizer has medicines that ambition three altered lung blight biomarkers, appearance absolute beforehand for patients which has been accomplished through a assorted and assiduous biologic development approach.”
The assurance and adeptness of VIZIMPRO was accustomed in ARCHER 1050, a randomized, multicenter, multinational, open-label study. Patients were adapted to accept unresectable, metastatic NSCLC with no above-mentioned analysis for metastatic ache or alternate ache with a minimum of 12 months advantageous afterwards achievement of systemic therapy; an Eastern Cooperative Oncology Accumulation (ECOG) achievement cachet of 0 or 1; EGFR exon 19 abatement or exon 21 L858R barter mutations. A absolute of 452 patients were randomized 1:1 to VIZIMPRO (n=227) or gefitinib (n=225). The primary endpoint was progression-free adaptation (PFS) as bent by addled Independent Radiologic Axial (IRC) review, and added adeptness outcomes included all-embracing acknowledgment amount (ORR), continuance of acknowledgment (DoR) and all-embracing adaptation (OS). A statistically cogent beforehand in PFS as bent by the IRC was accustomed for patients randomized to VIZIMPRO compared with gefitinib (HR = 0.59 [95% CI: 0.47, 0.74], p <0.0001). Median PFS in the VIZIMPRO accumulation was 14.7 months (95% CI: 11.1, 16.6) compared with 9.2 months (95% CI: 9.1, 11.0) in the gefitinib arm.
“EGFR-mutated avant-garde non-small corpuscle lung blight is a accepted illness, abnormally in the Asian population, and new analysis options will ultimately annual patients,” said Professor Tony Mok, MD, primary investigator for the ARCHER 1050 abstraction and Chair of Department of Analytic Oncology, The Chinese University of Hong Kong. “The allegation from ARCHER 1050 beforehand that VIZIMPRO should be advised as a new first-line analysis advantage for patients with EGFR-mutated non-small corpuscle lung blight exon 19 abatement or exon 21 L858R barter mutations.”
Amid 227 patients with EGFR-mutated metastatic NSCLC who accustomed VIZIMPRO in ARCHER 1050, the best accepted (> 20%) adverse reactions were diarrhea (87%), adventurous (69%), paronychia (64%), stomatitis (45%), decreased appetence (31%), dry bark (30%), decreased weight (26%), alopecia (23%), ahem (21%), and pruritus (21%). Austere adverse reactions occurred in 27 percent of patients advised with VIZIMPRO. The best accepted (≥1%) austere adverse reactions appear were diarrhea (2.2%) and interstitial lung ache (1.3%). The abounding prescribing advice for VIZIMPRO can be begin here.
“Today’s approval of VIZIMPRO is a absolute aftereffect of our charge to attention biologic development and convalescent outcomes for patients with mutation-driven lung cancers. Pfizer now has two medicines that can accouterment three altered forms of mutation-driven lung cancer: XALKORI for patients with ALK-positive or ROS1-positive non-small corpuscle lung blight and VIZIMPRO for patients with EGFR-mutated non-small corpuscle lung cancer,” said Mace Rothenberg, MD, arch development officer, Oncology, Pfizer All-around Artefact Development.
Earlier this year, the FDA accepted Priority Analysis for VIZIMPRO for the first-line analysis of patients with locally avant-garde or metastatic NSCLC with EGFR-activating mutations. The FDA grants Priority Analysis to medicines that may action cogent advances in analysis or may accommodate a analysis area no able analysis exists.
Pfizer is committed to ensuring that patients active with lung blight accept admission to this avant-garde therapy. Patients in the U.S. who are assigned VIZIMPRO accept admission to Pfizer Oncology TogetherTM, which offers alone accommodating abutment including banking abetment and added assets to advice them administer circadian activity with their condition.
About VIZIMPRO® (dacomitinib)
VIZIMPRO is a kinase inhibitor adumbrated for the first-line analysis of patients with metastatic non-small corpuscle lung blight (NSCLC) with epidermal beforehand agency receptor (EGFR) exon 19 abatement or exon 21 L858R barter mutations as detected by an FDA-approved test. VIZIMPRO was advised and accustomed beneath the FDA’s Priority Analysis program.
The recommended dosage of VIZIMPRO is 45 mg taken orally, already daily, with or afterwards food. If dosage abridgement is necessary, again the aboriginal dosage abridgement should be to 30 mg already circadian and added dosage abridgement should be to 15 mg already daily.
In 2012, Pfizer and SFJ Pharmaceuticals entered into a collaborative development acceding to conduct ARCHER 1050 beyond assorted sites. SFJ is a all-around biologic development company, which provides a altered and awful customized co-development partnering archetypal for the world’s top biologic and biotechnology companies. Beneath the acceding of this agreement, SFJ Pharmaceuticals provided the allotment and conducted the balloon to accomplish the analytic abstracts acclimated to abutment this application. Pfizer retains all rights to commercialize VIZIMPRO globally.
About ARCHER 1050
The adeptness of VIZIMPRO was accustomed in ARCHER 1050, a all-around Appearance 3 head-to-head balloon conducted in patients with unresectable, metastatic non-small corpuscle lung blight (NSCLC) harboring epidermal beforehand agency receptor (EGFR) exon 19 abatement or exon 21 L858R barter mutations, with no above-mentioned analysis for metastatic ache or alternate ache with a minimum of 12 months advantageous afterwards achievement of systemic therapy. A absolute of 452 patients were randomized 1:1 to VIZIMPRO 45mg (n=227) or gefitinib 250mg (n=225). Randomization was stratified by arena and EGFR alteration status. The above adeptness aftereffect admeasurement was PFS as bent by addled IRC review, and added adeptness outcomes included ORR, DoR and OS.
The hierarchical statistical testing acclimation was PFS followed by ORR and again OS. No academic testing of OS was conducted back the academic allegory of ORR was not statistically significant.
VIZIMPRO® (dacomitinib) IMPORTANT SAFETY INFORMATION FROM THE U.S. PRESCRIBING INFORMATION
There are no contraindications for VIZIMPRO.
Interstitial Lung Ache (ILD): Astringent and baleful ILD/pneumonitis occurred in patients advised with VIZIMPRO and occurred in 0.5% of the 394 VIZIMPRO-treated patients; 0.3% of cases were fatal. Monitor patients for pulmonary affection apocalyptic of ILD/pneumonitis. Withhold VIZIMPRO and promptly investigate for ILD in patients who present with deepening of respiratory affection which may be apocalyptic of ILD (e.g., dyspnea, cough, and fever). Assuredly abandon VIZIMPRO if ILD is confirmed.
Diarrhea: Astringent and baleful diarrhea occurred in patients advised with VIZIMPRO. Diarrhea occurred in 86% of the 394 VIZIMPRO-treated patients. Brand 3 or 4 diarrhea was appear in 11% of patients and 0.3% of cases were fatal. Withhold VIZIMPRO for Brand 2 or greater diarrhea until accretion to beneath than or according to Brand 1 severity, again resume VIZIMPRO at the aforementioned or a bargain dosage depending on the severity of diarrhea. Promptly admit anti-diarrheal analysis (loperamide or diphenoxylate hydrochloride with atropine sulfate) for diarrhea.
Dermatologic Adverse Reactions: Adventurous and exfoliative bark reactions occurred in patients advised with VIZIMPRO. Adventurous occurred in 78% of the 394 VIZIMPRO-treated patients. Brand 3 or 4 adventurous was appear in 21% of patients. Exfoliative bark reactions of any severity were appear in 7% of patients. Brand 3 or 4 exfoliative bark reactions were appear in 1.8% of patients. Withhold VIZIMPRO for assiduous Brand 2 or any Brand 3 or 4 dermatologic adverse acknowledgment until accretion to beneath than or according to Brand 1 severity, again resume VIZIMPRO at the aforementioned or a bargain dosage depending on the severity of the dermatologic adverse reaction. The accident and severity of adventurous and exfoliative bark reactions may admission with sun exposure. At the time of admission of VIZIMPRO, admit use of moisturizers and adapted measures to absolute sun exposure. Upon development of Brand 1 rash, admit analysis with contemporary antibiotics and contemporary steroids. Admit articulate antibiotics for Brand 2 or added astringent dermatologic adverse reactions.
Embryo-Fetal Toxicity: VIZIMPRO can annual fetal abuse back administered to a abundant woman. Admonish abundant women of the abeyant accident to the fetus. Admonish females of changeable abeyant to use able contraception during analysis with VIZIMPRO and for at atomic 17 canicule afterwards the final dose.
Adverse Reactions: The best accepted (>20%) adverse reactions were diarrhea (87%), rash (69%), paronychia (64%), stomatitis (45%), decreased appetence (31%), dry bark (30%), decreased weight (26%), alopecia (23%), ahem (21%), and pruritus (21%). The best accepted (≥1%) austere adverse reactions were diarrhea (2.2%) and interstitial lung ache (1.3%).
Biologic Interactions: Accessory use with a proton pump inhibitor (PPI) decreases dacomitinib concentrations, which may abate VIZIMPRO efficacy. Avoid the accessory use of PPIs with VIZIMPRO. As an another to PPIs, use locally-acting antacids or an H2-receptor antagonist. Administer VIZIMPRO at atomic 6 hours afore or 10 hours afterwards demography an H2-receptor antagonist. Accessory use of VIZIMPRO increases the absorption of drugs that are CYP2D6 substrates which may admission the accident of toxicities of these drugs. Avoid accessory use of VIZIMPRO with CYP2D6 substrates area basal increases in absorption of the CYP2D6 substrate may beforehand to austere or life-threatening toxicities.
Lactation: Because of the abeyant for austere adverse reactions in fed breed from VIZIMPRO, admonish women not to feed during analysis with VIZIMPRO and for at atomic 17 days afterwards the aftermost dose.
Hepatic Impairment: No dosage acclimation is recommended in patients with balmy or abstinent hepatic impairment. The recommended dosage of VIZIMPRO has not been accustomed for patients with astringent hepatic impairment.
Renal Impairment: No dosage acclimation is recommended for patients with balmy or abstinent renal impairment. The recommended dosage of VIZIMPRO has not been accustomed for patients with astringent renal impairment.
About XALKORI® (crizotinib)
XALKORI is a tyrosine kinase inhibitor (TKI) adumbrated for the analysis of patients with metastatic non-small corpuscle lung blight (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK) or ROS1-positive as detected by an FDA-approved test. XALKORI has accustomed approval for patients with ALK-positive NSCLC in added than 90 countries including Australia, Canada, China, Japan, South Korea and the European Union. XALKORI is additionally accustomed for ROS1-positive NSCLC in added than 60 countries.
XALKORI® Important Assurance Advice
Hepatotoxicity: Drug-induced hepatotoxicity with baleful aftereffect occurred in 0.1% of patients advised with XALKORI beyond analytic trials (n=1719). Transaminase elevations about occurred aural the aboriginal 2 months. Monitor alarmist action tests, including ALT, AST, and absolute bilirubin, every 2 weeks during the aboriginal 2 months of treatment, again already a month, and as clinically indicated, with added accepted echo testing for added alarmist transaminases, acrid phosphatase, or absolute bilirubin in patients who beforehand transaminase elevations. Assuredly abandon for ALT/AST acclivity >3 times ULN with circumstantial absolute bilirubin acclivity >1.5 times ULN (in the absence of cholestasis or hemolysis); otherwise, briefly append and dose-reduce XALKORI as indicated.
Interstitial Lung Ache (Pneumonitis): Severe, life-threatening, or baleful interstitial lung ache (ILD)/pneumonitis can occur. Beyond analytic trials (n=1719), 2.9% of XALKORI-treated patients had any brand ILD, 1.0% had Brand 3/4, and 0.5% had baleful ILD. ILD about occurred aural 3 months afterwards admission of treatment. Monitor for pulmonary affection apocalyptic of ILD/pneumonitis. Exclude added abeyant causes and assuredly abandon XALKORI in patients with drug-related ILD/pneumonitis.
QT Breach Prolongation: QTc assiduity can occur. Beyond analytic trials (n=1616), 2.1% of patients had QTcF (corrected QT by the Fridericia method) ≥500 ms and 5.0% had an admission from baseline QTcF ≥60 ms by automatic machine-read appraisal of ECGs. Avoid use in patients with complete continued QT syndrome. Monitor ECGs and electrolytes in patients with congestive affection failure, bradyarrhythmias, electrolyte abnormalities, or who are demography medications that prolong the QT interval. Assuredly abandon XALKORI in patients who beforehand QTc >500 ms or ≥60 ms change from baseline with Torsade de pointes, polymorphic ventricular tachycardia, or signs/symptoms of austere arrhythmia. Withhold XALKORI in patients who beforehand QTc >500 ms on at atomic 2 abstracted ECGs until accretion to a QTc ≤480 ms, again resume at a bargain dose.
Bradycardia: Appropriate bradycardia can occur. Beyond analytic trials, bradycardia occurred in 12.7% of patients advised with XALKORI (n=1719). Avoid use in aggregate with added agents accepted to annual bradycardia. Monitor affection amount and claret burden regularly. In cases of appropriate bradycardia that is not life-threatening, authority XALKORI until accretion to asymptomatic bradycardia or to a affection amount of ≥60 bpm, amend the use of accessory medications, and acclimatize the dosage of XALKORI. Assuredly abandon for life-threatening bradycardia due to XALKORI; however, if associated with accessory medications accepted to annual bradycardia or hypotension, authority XALKORI until accretion to asymptomatic bradycardia or to a affection amount of ≥60 bpm. If accessory medications can be adapted or discontinued, restart XALKORI at 250 mg already circadian with accepted monitoring.
Astringent Beheld Loss: Beyond analytic trials, the accident of Brand 4 beheld acreage birthmark with eyes accident was 0.2% (n=1719). Abandon XALKORI in patients with new admission of astringent beheld accident (best adapted eyes beneath than 20/200 in one or both eyes). Perform an ophthalmological evaluation. There is bereft advice to characterize the risks of resumption of XALKORI in patients with a astringent beheld loss; a accommodation to resume should accede the abeyant allowances to the patient.
Eyes Disorders: Best frequently beheld impairment, photopsia, blurred eyes or brittle floaters, occurred in 63.1% of 1719 patients. The majority (95%) of these patients had Brand 1 beheld adverse reactions. 0.8% of patients had Brand 3 and 0.2% had Brand 4 beheld impairment. The majority of patients on the XALKORI accoutrements in Studies 1 and 2 (>50%) appear beheld disturbances which occurred at a abundance of 4-7 canicule anniversary week, lasted up to 1 minute, and had balmy or no appulse on circadian activities.
Embryo-Fetal Toxicity: XALKORI can annual fetal abuse back administered to a abundant woman. Admonish of the abeyant accident to the fetus. Admonish females of changeable abeyant and males with changeable ally of changeable abeyant to use able contraception during analysis and for at atomic 45 canicule (females) or 90 canicule (males) respectively, afterward the final dosage of XALKORI.
ROS1-positive Metastatic NSCLC: Assurance was evaluated in 50 patients with ROS1-positive metastatic NSCLC from a single-arm study, and was about constant with the assurance contour of XALKORI evaluated in patients with ALK-positive metastatic NSCLC. Eyes disorders occurred in 92% of patients in the ROS1 study; 90% of patients had Brand 1 eyes disorders and 2% had Brand 2.
Adverse Reactions: Assurance was evaluated in a appearance 3 abstraction in ahead basic patients with ALK-positive metastatic NSCLC randomized to XALKORI (n=171) or chemotherapy (n=169). Austere adverse contest were appear in 34% of patients advised with XALKORI, the best accepted were dyspnea (4.1%) and pulmonary array (2.9%). Baleful adverse contest in XALKORI-treated patients occurred in 2.3% of patients, consisting of catchbasin shock, astute respiratory failure, and diabetic ketoacidosis. Accepted adverse reactions (all grades) occurring in ≥25% and added frequently (≥5%) in patients advised with XALKORI vs chemotherapy were eyes ataxia (71% vs 10%), diarrhea (61% vs 13%), edema (49% vs 12%), airsickness (46% vs 36%), ache (43% vs 30%), high respiratory infection (32% vs 12%), dysgeusia (26% vs 5%), and belly affliction (26% vs 12%). Brand 3/4 reactions occurring at a ≥2% college accident with XALKORI vs chemotherapy were QT assiduity (2% vs 0%), esophagitis (2% vs 0%), and ache (2% vs 0%). In patients advised with XALKORI vs chemotherapy, the afterward occurred: acclivity of ALT (any brand [79% vs 33%] or Brand 3/4 [15% vs 2%]); acclivity of AST (any brand [66% vs 28%] or Brand 3/4 [8% vs 1%]); neutropenia (any brand [52% vs 59%] or Brand 3/4 [11% vs 16%]); lymphopenia (any brand [48% vs 53%] or Brand 3/4 [7% vs 13%]); hypophosphatemia (any brand [32% vs 21%] or Brand 3/4 [10% vs 6%]). In patients advised with XALKORI vs chemotherapy, renal cysts occurred (5% vs 1%). Nausea (56%), decreased appetence (30%), fatigue (29%), and neuropathy (21%) additionally occurred in patients demography XALKORI.
Biologic Interactions: Exercise attention with accessory use of abstinent CYP3A inhibitors. Avoid grapefruit or grapefruit abstract which may admission claret concentrations of crizotinib. Avoid accessory use of able CYP3A inducers and inhibitors. Avoid accessory use of CYP3A substrates with attenuated ameliorative ambit in patients demography XALKORI. If accessory use of CYP3A substrates with attenuated ameliorative ambit is adapted in patients demography XALKORI, dosage reductions of the CYP3A substrates may be adapted due to adverse reactions.
Lactation: Because of the abeyant for adverse reactions in fed infants, admonish females not to feed during analysis with XALKORI and for 45 canicule afterwards the final dose.
Hepatic Impairment: Crizotinib concentrations added in patients with above-mentioned abstinent (any AST and absolute bilirubin >1.5x ULN and ≤3x ULN) or astringent (any AST and absolute bilirubin >3x ULN) hepatic impairment. Abate XALKORI dosage in patients with abstinent or astringent hepatic impairment. The recommended dosage of XALKORI in patients with above-mentioned abstinent hepatic crime is 200 mg orally alert circadian or with above-mentioned astringent hepatic crime is 250 mg orally already daily.
Renal Impairment: Decreases in estimated glomerular filtration amount occurred in patients advised with XALKORI. Administer XALKORI at a starting dosage of 250 mg taken orally already circadian in patients with astringent renal crime (CLcr <30 mL/min) not acute dialysis.
For added advice and abounding prescribing information, amuse visit www.XALKORI.com.
About Non-Small Corpuscle Lung Blight
Lung blight is the arch annual of blight afterlife worldwide.1 NSCLC accounts for about 85 percent of lung blight cases and charcoal difficult to treat, decidedly in the metastatic setting.2 Approximately 75 percent of NSCLC patients are diagnosed backward with metastatic or avant-garde ache area the five-year adaptation amount is alone bristles percent.3,4,5
EGFR is a protein that helps beef abound and divide. Back the EGFR gene is mutated it can annual the protein to be overactive consistent in blight beef to form. EGFR mutations may action in 10 to 35 percent of NSCLC tumors globally, and best accepted activating mutations are deletions in exon 19 and exon 21 L858R substitutions, which calm annual for added than 80 percent of accepted activating EGFR mutations. The ache is associated with low adaptation ante and ache progression charcoal a challenge.5,6
About Pfizer in Lung Blight
Pfizer Oncology is committed to acclamation the unmet needs of a ample ambit of patients with lung cancer, the arch annual of cancer-related afterlife accepted and a decidedly difficult-to-treat disease. Pfizer strives to abode the assorted and evolving needs of patients with non-small corpuscle lung blight (NSCLC) by developing active and safe therapies, including biomarker-driven therapies and combinations with immuno-oncology (IO) agents. By accumulation arch accurate insights with a patient-centric approach, Pfizer is always advancing its assignment to bout the appropriate accommodating with the appropriate anesthetic at the appropriate time. Through our analysis activity and accord efforts, we are committed to carrying renewed achievement to patients active with NSCLC.
About Pfizer Oncology
At Pfizer Oncology, we are committed to advancing medicines wherever we accept we can accomplish a allusive aberration on the lives of patients. Today, Pfizer Oncology has an industry-leading portfolio of 11 accustomed blight medicines beyond 19 indications, including , prostate, kidney, lung and hematology. We additionally accept one of the centermost oncology biosimilars pipelines, with two medicines accustomed globally and several assets in mid to late-stage development for the analysis of blight or as admiring care. Pfizer Oncology is appetite to change the aisle of cancer.
Pfizer Inc: Working calm for a convalescent world®
At Pfizer, we administer science and our all-around assets to accompany therapies to bodies that extend and decidedly beforehand their lives. We strive to set the accepted for quality, assurance and amount in the discovery, development and accomplish of bloom affliction products. Our all-around portfolio includes medicines and vaccines as able-bodied as abounding of the world’s best-known customer bloom affliction products. Every day, Pfizer colleagues assignment beyond developed and arising markets to beforehand wellness, prevention, treatments and cures that claiming the best feared diseases of our time. Constant with our albatross as one of the world’s arch avant-garde biopharmaceutical companies, we coact with bloom affliction providers, governments and bounded communities to abutment and aggrandize admission to reliable, affordable bloom affliction about the world. For added than 150 years, we accept formed to accomplish a aberration for all who await on us. We commonly column advice that may be important to investors on our website at www.pfizer.com. In addition, to apprentice more, amuse appointment us on www.pfizer.com and chase us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube, and like us on Facebook at Facebook.com/Pfizer.
DISCLOSURE NOTICE: The advice independent in this absolution is as of September 27, 2018. Pfizer assumes no obligation to amend advanced statements independent in this absolution as the aftereffect of new advice or approaching contest or developments.
This absolution contains advanced advice about VIZIMPRO® (dacomitinib) and an approval in the U.S. for the first-line analysis of patients with metastatic NSCLC with EGFR exon 19 abatement or exon 21 L858R barter mutations as detected by an FDA-approved test, and Pfizer Oncology, including their abeyant benefits, that involves abundant risks and uncertainties that could annual 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 VIZIMPRO; the uncertainties inherent in analysis and development, including the adeptness to accommodated advancing analytic balloon admission and achievement dates and authoritative acquiescence dates, as able-bodied as the achievability of abortive analytic balloon results, including abortive new analytic abstracts and added analyses of absolute analytic data; the accident that analytic balloon abstracts are accountable to differing interpretations, and, alike back we appearance abstracts as acceptable to abutment the assurance and/or capability of a artefact candidate, authoritative authorities may not allotment our angle and may crave added abstracts or may abjure approval altogether; whether authoritative authorities will be annoyed with the architecture of and after-effects from our analytic studies; whether and back new biologic applications may be filed in any added jurisdictions for VIZIMPRO or for any added oncology products; whether and back any such applications may be accustomed by authoritative authorities, which will depend on the appraisal by such authoritative authorities of the benefit-risk contour appropriate by the accumulation of the adeptness and assurance advice submitted, and, if approved, whether VIZIMPRO or any such added oncology articles will be commercially successful; decisions by authoritative authorities apropos labeling and added affairs that could affect the availability or bartering abeyant of VIZIMPRO or any added oncology products; 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, 2017 and in its consecutive letters on Anatomy 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Advice 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 Exchange Commission and accessible at www.sec.gov and www.pfizer.com.
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