Tasigna (Nilotinib) - Summary

TASIGNA SUMMARY

Tasigna (nilotinib) belongs to a pharmacologic class of drugs known as kinase inhibitors.

Tasigna (nilotinib) is indicated for the treatment of chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (CML) in adult patients resistant or intolerant to prior therapy that included imatinib. The effectiveness of Tasigna is based on hematologic and cytogenetic response rates [ See Clinical Studies (14)]. There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival.

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NEWS HIGHLIGHTS

Media Articles Related to Tasigna (Nilotinib)

Data show new Roche leukemia drug may improve on Rituxan
Source: Yahoo! Health News [2013.05.16]
By Bill Berkrot (Reuters) - An experimental leukemia treatment that Roche Holding AG hopes will improve upon its best-selling cancer drug Rituxan delayed disease progression twice as long as chemotherapy, according to preliminary trial data releas...

Possible New Acute Leukemia Marker Treatment Target Identified
Source: Genetics News From Medical News Today [2013.05.15]
A study has identified microRNA-155 as a new independent prognostic marker and treatment target in patients with acute myeloid leukemia that has normal-looking chromosomes under the microscope (that is, cytogenetically normal acute myeloid leukemia, or CN-AML). The study was led by researchers at the Ohio State University Comprehensive Cancer Center - Arthur G...

Drug Combo Looks Promising For Chronic Lymphocytic Leukemia
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2013.05.15]
Doctors at Dartmouth-Hitchcock's Norris Cotton Cancer Center (NCCC) have found a combination of drugs to potentially treat chronic lymphocytic leukemia (CLL) more effectively. The research was published online recently, and it will appear as a letter in the journal Leukemia, a publication of the prestigious Nature Publishing Group. The study helps address a basic problem of treating CLL...

Leukemia Drug Prevents Build-Up Of Toxic Brain Protein
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2013.05.14]
Researchers at Georgetown University Medical Center have used tiny doses of a leukemia drug to halt accumulation of toxic proteins linked to Parkinson's disease in the brains of mice. This finding provides the basis to plan a clinical trial in humans to study the effects...

Genetic Test Identifies Two Types Of Leukemia; Discovery Provides Insights Into New Treatment Approach
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2013.05.14]
Research method used by scientists with the Knight Cancer Institute at Oregon Health & Science University shows promise in accelerating advances in personalized cancer medicine Patients with two forms of leukemia, who currently have no viable treatment options, may benefit from existing drugs developed for different types of cancer, according to a study conducted by research...

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Published Studies Related to Tasigna (Nilotinib)

Nilotinib versus imatinib for the treatment of patients with newly diagnosed chronic phase, Philadelphia chromosome-positive, chronic myeloid leukaemia: 24-month minimum follow-up of the phase 3 randomised ENESTnd trial. [2011.09]
BACKGROUND: Nilotinib has shown greater efficacy than imatinib in patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukaemia (CML) in chronic phase after a minimum follow-up of 12 months. We present data from the Evaluating Nilotinib Efficacy and Safety in clinical Trials-newly diagnosed patients (ENESTnd) study after a minimum follow-up of 24 months... INTERPRETATION: Nilotinib continues to show better efficacy than imatinib for the treatment of patients with newly diagnosed CML in chronic phase. These results support nilotinib as a first-line treatment option for patients with newly diagnosed disease. FUNDING: Novartis. Copyright (c) 2011 Elsevier Ltd. All rights reserved.

Comparative efficacy of nilotinib and dasatinib in newly diagnosed chronic myeloid leukemia: a matching-adjusted indirect comparison of randomized trials. [2011.06]
OBJECTIVE: Nilotinib and dasatinib have not been directly compared in a randomized trial for the treatment of newly diagnosed chronic myeloid leukemia in the chronic phase (CML-CP). The purpose of this study was to indirectly compare rates of major molecular response (MMR), progression-free survival (PFS) and overall survival by month 12 with nilotinib and dasatinib treatment of newly diagnosed CML-CP... CONCLUSION: Nilotinib was associated with significantly higher rates of MMR and overall survival compared with dasatinib by month 12 in the treatment of newly diagnosed CML-CP.

Nilotinib as frontline therapy for patients with newly diagnosed Ph+ chronic myeloid leukemia in chronic phase: results from the Japanese subgroup of ENESTnd. [2011.05]
Recent results from the phase 3 ENESTnd (Evaluating Nilotinib Efficacy and Safety in Clinical Trials-Newly Diagnosed Patients) study have demonstrated superiority of nilotinib over imatinib for the treatment of newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (CML-CP)...

Nilotinib: evaluation and analysis of its role in chronic myeloid leukemia. [2011.02]
Nilotinib, formally known as AMN107, is a second-generation tyrosine kinase inhibitor, rationally designed from its revolutionary parent compound imatinib, to produce a 30-40-fold enhancement in the inhibition of the BCR-ABL1-derived oncoprotein associated with chronic myeloid leukemia... With the emergence of supportive trial data, it is likely to have a leading role both in the front-line management of newly presenting patients and in the second-line treatment of patients resistant to or intolerant of imatinib and other second-line agents.

Effects of nilotinib on single-dose warfarin pharmacokinetics and pharmacodynamics: a randomized, single-blind, two-period crossover study in healthy subjects. [2011]
BACKGROUND AND OBJECTIVE: Nilotinib (Tasigna(R)), a highly selective and potent BCR-ABL tyrosine kinase inhibitor, is approved for the treatment of chronic myeloid leukaemia in the chronic phase (CML-CP) and the accelerated phase (CML-AP) in patients resistant or intolerant to prior therapy, including imatinib. Nilotinib has shown competitive inhibition of cytochrome P450 enzyme (CYP) 2C9 in vitro, but its effect on CYP2C9 activity in humans is unknown. This study evaluated the effects of nilotinib on the pharmacokinetics and pharmacodynamics of warfarin, a sensitive CYP2C9 substrate, in healthy subjects... CONCLUSION: The study results demonstrate that nilotinib has no effect on single-dose warfarin pharmacokinetics and pharmacodynamics. This implies that nilotinib is unlikely to inhibit CYP2C9 activity in human subjects. These findings suggest that warfarin and nilotinib may be used concurrently as needed.

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Clinical Trials Related to Tasigna (Nilotinib)

Trial of Tasigna (Nilotinib) 400 mg Twice Daily Alone or With Gleevec (Imatinib Mesylate) 400 mg Daily for Patients With Advanced Gastrointestinal Stromal Tumor (GIST) [Recruiting]
Patients with advanced GIST are treated with imatinib. This study seeks to look at a new therapeutic agent at the time of tumor progression following treatment with 600-800 mg daily of imatinib. The study is looking to see if Nilotinib (tasigna) alone or in combination with imatinib (gleevec) is more effective at controlling disease.

Study of Nilotinib in Ph+ CML-CP Patients With Low Imatinib Trough Plasma Concentrations [Recruiting]
This study is to determine the number of European Leukemia Network (ELN)guideline defined treatment failure events from time of study entry in CML-CP patients with low imatinib trough concentrations treated with nilotinib.

An Exploratory Trial to Assess the Improvement of Adverse Events in Chronic Myelogenous Leukemia Patients Treated With Imatinib When Switched to Nilotinib Treatment [Recruiting]
The purpose of this exploratory study will be to examine changes in chronic low grade chronic adverse events, measured by Common Terminology Criteria for Adverse Events (CTCAE) grading, when patients are switched from imatinib to nilotinib therapy.

Imatinib Mesylate (Glivec) as Maintenance Therapy After Cytogenetic Response With Nilotinib (AMN107, Tasigna) First Line in Newly Diagnosed Chronic Myelogenous Leukemia [Recruiting]
The results of the International Randomized Study of Interferon and STI571 (IRIS) trial indicate that in patients with chronic phase CML treated with first line imatinib, achievement of a complete or partial cytogenetic response (CCyR or PCyR) at 12 months is associated with a significantly better progression-free survival (PFS).

Second generation tyrosine kinase inhibitors such as nilotinib can overcome imatinib resistance because of greater potency to bind to BCR-ABL. Recent results indicate that, in patients with previously untreated chronic phase CML, nilotinib results in a faster and higher rate of CCyR or PCyR than imatinib. However, nilotinib use is associated with diet restriction and much higher financial cost.

The primary objective of this study is to evaluate the ability of imatinib to maintain a complete cytogenetic response (CcyR) in patients who achieved a CCyR after 12 months of first-line treatment with nilotinib.

Study of Tasigna�/Nilotinib (AMN107) in Neurofibromatosis (NF1) Patients With Plexiform Neurofibromas [Recruiting]
The purpose of this Pilot Study is to determine if NF1 patients with plexiform neurofibromas treated with Tasgina® respond to therapy.

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Reports of Suspected Tasigna (Nilotinib) Side Effects

Fatigue (185),  Nausea (175),  Death (167),  Dyspnoea (166),  Rash (153),  Pruritus (134),  Electrocardiogram QT Prolonged (126),  Pyrexia (120),  Headache (110),  Neoplasm Malignant (110), more >>