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(Thomson Reuters ONE via COMTEX) — Novartis International AG / Novartis presents new abstracts from ample European abstraction reinforcing the account of first-line Tasigna(R) in newly-diagnosed patients with CML . Processed and transmitted by NASDAQ OMX Corporate Solutions. The issuer is alone amenable for the agreeable of this announcement.
– Patients on Tasigna accomplished accelerated and aerial ante of atomic acknowledgment with a absolute low amount of progression to avant-garde ache
– ENEST1st abstracts affirm the favorable benefit/risk contour of Tasigna in newly-diagnosed CML patients apparent in the cardinal ENESTnd abstraction
– Assurance after-effects in this Appearance 3b abstraction of added than 1,000 European patients were constant with the accepted assurance contour of Tasigna
Basel, June 13, 2015 – Novartis today appear after-effects from the Appearance 3b ENEST1st abstraction in over 1,000 patients with newly-diagnosed, BCR-ABL absolute abiding myeloid leukemia (CML), acknowledging the allowances of first-line Tasigna assay apparent in beforehand trials. The final after-effects of this ample study, conducted in 26 European countries, were presented at the 20th Congress of the European Hematology Association (EHA) in Vienna.
“These after-effects appearance patients with BCR-ABL absolute CML in abiding appearance accepting first-line assay with Tasigna accomplished accelerated and aerial ante of atomic acknowledgment and had a absolute low amount of progression to avant-garde disease,” said Dr. Andreas Hochhaus, Head of the Department of Hematology and Medical Oncology, Jena University Hospital, Germany. “These allegation from 26 countries, which are a accord of 307 balloon sites and 14 connected laboratories ecology the accident of MR4.0 as primary endpoint, affirm and accompaniment abstracts from the cardinal ENESTnd trial.”
The primary endpoint in ENEST1st was the amount of Atomic Acknowledgment 4 (MR4.0) at 18 months. MR4.0, which is a 4 log abridgement in BCR-ABL, represents a absolute low akin of apparent BCR-ABL, the account of Ph CML (measured as BCR-ABL <=0.01% on the International Scale [BCR-ABLIS] or ephemeral BCR-ABL in cDNA with >=10,000 ABL transcripts).
At 18 months, 38.4% of Tasigna-treated patients (n=1,052) accomplished MR4.0. These abstracts authenticate aerial ante of aboriginal and abysmal atomic acknowledgment with Tasigna. The amount of ache progression in the abstraction was low, with six patients, or 0.6%, advancing to the accelerated phase/blast crisis date of the disease. Despite the college average age of patients in ENEST1st than in antecedent Tasigna studies, the assurance after-effects were constant with the accepted assurance contour of Tasigna. The best accepted adverse contest (AE) were rash, crawling and headache. Brand 3/4 AEs accompanying to hepatotoxicity and pancreatitis occurred in 0.4% and 0.6% of patients, respectively. Brand 3/4 thrombocytopenia (low claret platelet count) and neutropenia (low white claret corpuscle count) occurred in 6.0% and 4.8% of patients, respectively.
“Our charge to CML charcoal able and is exemplified by this trial, as able-bodied as added abstraction of abysmal atomic acknowledgment with Tasigna and the achievability for some patients with Ph CML to stop their assay and accomplish abiding treatment-free remission,” said Bruno Strigini, President, Novartis Oncology. “In addition, we are developing new compounds with altered mechanisms of action, which could advice abode the attrition to absolute medications that some patients experience.”
ENEST1st Abstraction Details
ENEST1st (Evaluating Nilotinib Adeptness and Assurance Balloon as First-Line Treatment) is a Appearance 3b, open-label abstraction that evaluated the adeptness and assurance of Tasigna 300 mg alert circadian (BID) in a ample citizenry of developed patients with anew diagnosed CML-chronic appearance (CP) application a arrangement of 14 European Assay and Outcome Abstraction (EUTOS) connected laboratories to adviser MR.
The abstraction was conducted in 26 European countries with 1,089 patients treated. Specifically, 90.3% of patients were Philadelphia chromosome absolute (Ph ) and 97.0% had archetypal BCR-ABL transcripts. Sokal accident array were low, average and aerial in 34.6%, 37.5% and 18.1% of patients, appropriately (9.8% missing). EUTOS array were low in 82.6% and aerial in 8.6% of patients (8.7% missing). A absolute of 80.9% of patients completed 24 months of treatment; 19.1% discontinued early, best frequently due to AEs (10.7%). The AEs apparent in this abstraction were constant with the accepted assurance contour of Tasigna. Thirteen patients (1.2%) died by 24 months; of those 13 deaths, one was attributed to CML progression (16 months afterwards abstraction biologic discontinuation).
The primary endpoint was the amount of MR4.0 (BCR-ABL <=0.01% on the International Scale [BCR-ABLIS] or ephemeral BCR-ABL in cDNA with >=10,000 ABL transcripts) at 18 months. The MR4.0 amount in all advised patients with <=3 months of above-mentioned Glivec assay (n=1,052) was 38.4% at 18 months and 40.4% at 24 months. As adjourned with multicenter atomic monitoring, MR ante in this abstraction provided -to-be acceptance of the centrally advised MR ante in the cardinal ENESTnd study. In ENESTnd, Tasigna accustomed college ante of aboriginal and added abiding atomic response, including MR4.5, and a bargain accident of progression compared to Glivec.
Consistent with above-mentioned studies, ENEST1st accustomed the accent of aboriginal atomic acknowledgment to frontline treatment. Atomic testing can alter in countries about the world, appropriately reinforcing the accent of these constant findings. Patients with BCR-ABL1IS <= 1% at 3 months accomplished the accomplished ante of MMR, MR4.0, and MR4.5 at after time points, while no accommodating with BCR-ABL1IS > 10% at 3 months accomplished MR4.0 by 24 months.
Within the abstraction continuance of two years, the best accepted AEs of any account were adventurous (21.4%), crawling (16.5%), and cephalalgia (15.2%). Abstraction board achieve almost low ante of these AEs may reflect improvements in the administering of Tasigna-treated patients. Peripheral avenue ache (PAD) occurred in 1.9% of patients, ischemic affection ache (IHD) in 3.4%, and ischemic cerebrovascular altitude (ICVE) in 0.8%; 0.6% of patients had balance aqueous about the lung. These allegation are constant with what was apparent in ENESTnd at the aforementioned continuance of therapy. The best frequently empiric brand 3/4 biochemical abnormalities were decreased phosphate (14.3%) and added lipase (7.2%); glucose and lipid ecology was not allowable in the abstraction protocol.
Novartis Charge to CML
Over the accomplished several decades, Novartis assay in Ph CML has helped transform this baleful ache to a abiding action and today, the aggregation continues its abiding charge to the all-around CML community.
About Tasigna (nilotinib)
Tasigna(R) (nilotinib) is accustomed in added than 110 countries for the assay of abiding appearance and accelerated appearance Philadelphia chromosome-positive abiding myelogenous leukemia (Ph CML) in developed patients aggressive or antipathetic to at atomic one above-mentioned therapy, including Glivec(R) (imatinib), and in added than 85 countries for the assay of developed patients with anew diagnosed Ph CML in abiding phase.
Tasigna Important Assurance Advice
Use with attention in patients with amoral or cogent cardiac ache and in patients who accept or may advance assiduity of QTc. Low levels of potassium or magnesium charge be adapted above-mentioned to Tasigna administration. Adviser carefully for an aftereffect on the QTc interval. Baseline ECG is recommended above-mentioned to initiating assay and as clinically indicated. Uncommon cases (0.1 to 1%) of abrupt afterlife accept been appear in analytic studies in patients with cogent accident factors.
Use with attention in patients with alarmist impairment, with a history of pancreatitis and with absolute gastrectomy. Patients with attenuate ancestral problems of galactose intolerance, astringent lactase absence or glucose-galactose malabsorption should not use Tasigna. Tasigna may account fetal abuse in abundant women. Women demography Tasigna should not breastfeed.
The best common Brand 3 or 4 adverse contest are hematological (neutropenia and thrombocytopenia) which are about capricious and usually managed by denial Tasigna briefly or dosage reduction. Adviser claret counts regularly. Pancreatitis has been reported. The best common non-hematologic adverse contest were rash, pruritus, nausea, fatigue, headache, alopecia, myalgia, ache and diarrhea. Best of these adverse contest were balmy to abstinent in severity.
Please see abounding Prescribing Advice accessible at www.tasigna.com.
The above absolution contains advanced statements that can be articular by words such as “commitment,” “remains,” “further study,” “possibility,” “developing,” “could,” “continues,” “long-standing,” or agnate terms, or by accurate or adumbrated discussions apropos abeyant new break or labeling for Tasigna, or apropos abeyant approaching revenues from Tasigna. You should not abode disproportionate assurance on these statements. Such advanced statements are based on the accepted behavior and expectations of administering apropos approaching events, and are accountable to cogent accepted and alien risks and uncertainties. Should one or added of these risks or uncertainties materialize, or should basal assumptions prove incorrect, absolute after-effects may alter materially from those set alternating in the advanced statements. There can be no agreement that Tasigna will be submitted or accustomed for any added break or labeling in any market, or at any accurate time. Nor can there be any agreement that Tasigna will be commercially acknowledged in the future. In particular, management’s expectations apropos Tasigna could be afflicted by, amid added things, the uncertainties inherent in assay and development, including abrupt analytic balloon after-effects and added assay of absolute analytic data; abrupt authoritative accomplishments or delays or government adjustment generally; the company’s adeptness to access or advance proprietary bookish acreage protection; accepted bread-and-butter and industry conditions; all-around trends against bloom affliction amount containment, including advancing appraisement pressures; abrupt accomplishment issues, and added risks and factors referred to in Novartis AG’s accepted Form 20-F on book with the US Securities and Exchange Commission. Novartis is accouterment the advice in this columnist absolution as of this date and does not undertake any obligation to amend any advanced statements independent in this columnist absolution as a aftereffect of new information, approaching contest or otherwise.
Novartis provides avant-garde healthcare solutions that abode the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a adapted portfolio to best accommodated these needs: avant-garde medicines, eye affliction and cost-saving all-encompassing pharmaceuticals. Novartis is the alone all-around aggregation with arch positions in these areas. In 2014, the Group accomplished net sales of USD 58.0 billion, while R&D throughout the Group amounted to about USD 9.9 billion (USD 9.6 billion excluding crime and acquittal charges). Novartis Group companies apply about 120,000 full-time-equivalent associates. Novartis articles are accessible in added than 180 countries about the world. For added information, amuse appointment http://www.novartis.com.
Novartis is on Twitter. Sign up to chase @Novartis at http://twitter.com/novartis.
 Tsai, J, et al. Adeptness and assurance of frontline nilotinib in 1089 European patients with CML
in abiding phase: ENEST1st Final Analysis. Oral Presentation. Abstract #S486. 20th Congress of the European Hematology Association. 2015. Vienna, Austria.
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Form 8 Question 8b Five Things You Should Know About Form 8 Question 8b – form 1065 question 3b
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