Tasigna (Nilotinib) - Chronic Myeloid Leukemia - CML


''Nilotinib, in the form of the hydrochloride monohydrate salt, is a tyrosine kinase inhibitor...
It was approved as Tasigna® in the USA and the EU for drug-resistant chronic myelogenous leukemia (CML). In June 2006, a Phase I clinical trial found nilotinib, also known by its clinical code AMN107, has a relatively favorable safety profile and shows activity in cases of CML resistant to treatment with imatinib (Gleevec®), another tyrosine kinase inhibitor currently used as a first-line treatment. In that study 92% of patients (already resistant or unresponsive to Gleevec®) achieved a normal white blood cell counts after five months of treatment... ​
​'Extract of Wikipedia

​See also the List of side effects 

CLINICAL TRIALS

​A phase I clinical trial of ruxolitinib in combination with nilotinib in chronic myeloid leukemia patients with molecular evidence of disease
November 2018,    PubMed
                     All clinical trials with nilotinib
​ARTICLES

Cardiovascular events and atherogenic lipid profile in chronic myeloid leukemia patients treated with nilotinib versus imatinib
July 20, 2021, PubMed

Nilotinib-induced bone marrow CD34+/lin-Ph+ cells early clearance in newly diagnosed CP-Chronic Myeloid Leukemia: Final report of the PhilosoPhi34 study
July 9, 2021, MDLinx

Ultrasound arterial anomalies in patients exposed to nilotinib therapy for chronic myeloid leukemia
March 6, 2021, PubMed

Nilotinib appears safe and affects biomarkers in Alzheimer's disease clinical trial
May 29, 2020, Medical Xpress

Experts Establish Optimal Dosing of Nilotinib for Newly Diagnosed CML
April 14, 2020, Oncology Learning Network

Food-effect study of nilotinib in chronic myeloid leukaemia (NiFo study): enabling dose reduction and relief of treatment burden
April 3, 2020, PubMed
 
Long-term results of a phase 2 trial of nilotinib 400 mg twice daily in newly diagnosed patients with chronic-phase chronic myeloid leukemia
January 31, 2020, Physicien”s weekly

Nilotinib Therapy Safe, Effective for Certain Patients With CML
January 16, 2020, Oncology Learning Network

Long-Term Outcomes in Patients with Chronic Myeloid Leukemia in Chronic Phase Receiving Frontline Nilotinib Versus Imatinib: Enestnd 10-Year Analysis
November 13, 2019, ASH2019

Leukemia drug shows promise for treating a childhood brain cancer - nilotinib
September 2019,  Medical Xpress

First case report of latent tuberculosis reactivation complicating treatment with nilotinib in chronic myeloid leukemia
Jun 25, 2019, Synapse.
​
Successful determination of nilotinib dosage by therapeutic drug monitoring in a patient with chronic myeloid leukemia developing hepatic dysfunction: A case report   
June 14, 2019, PubMed       

Treatment-Free Remission After Nilotinib May Be Durable in Chronic Myeloid Leukemia
June 3, 2019, Hematology Advisor

ENESTop 192-week results: Treatment-free remission (TFR) in patients (pts) with chronic myeloid leukemia in chronic phase (CML-CP) after stopping second-line (2L) nilotinib (NIL)
May 26, 2019,  Journal of Clinical Oncology

The natural history of vascular and other complications in patients treated with nilotinib for chronic myeloid leukemia
March 2019, Blood Advances

Comparison of the clinical outcomes of nilotinib and dasatinib therapies in newly diagnosed patients in the chronic phase of chronic myeloid leukemia: a retrospective analysis
September 2018, PubMed

Nilotinib May Lead to Increased Rates of Treatment-Free Remission in Chronic-Phase CML
June 3, 2018, Cancer Therapy Advisor

New Novartis data presented at ASCO find nearly half of CML patients treated with Tasigna® remain in remission almost three years after stopping therapy
June 2, 2018, PR Newswire
​
Tasigna – Atherosclerosis  WARNING
May 11, 2018, US Recall News

Second-line Nilotinib May Lead to Treatment-Free Remission in Chronic Phase CML
March 5, 2018,  Oncology Nurse Advisor

Nilotinib Can Be Discontinued in Some Patients with Chronic Myelogenous Leukemia
January 19, 2018,  National Cancer Institute

MolecularMD Gets FDA Authorization for Companion Dx to Novartis CML Drug
December 27, 2017, GenomeWeb

FDA Updates Labeling for Nilotinib: Treatment Can Be Stopped
December 22, 2017, Medscape

Arterial Thrombotic Events Associated With First-line Nilotinib for CML in Older Adults
December 11, 2017, Oncology Nurses Advisor

Results from Enestgoal: A Phase 2 Study of Treatment-Free Remission (TFR) in Patients (pts) with Chronic Myeloid Leukemia in Chronic Phase (CML-CP) Who Switched from Imatinib to Nilotinib
​December 2017, ASH2017

Nilotinib Versus Nilotinib Combined to Pegylated-Interferon Alfa 2a in First-Line Chronic Phase Chronic Myelogenous Leukemia Patients. Interim Analysis of a Phase III Trial
​December 2017, ASH2017

Cardiovascular Scoring and Age-Related Mutations Predict the Occurrence of Adverse Vascular Events in CML Patients during Nilotinib Therapy
​December 2017, ASH2017

Molecular Responses after Switching from a Standard-Dose Twice-Daily Nilotinib Regimen to a Reduced-Dose Once-Daily Schedule in Patients with CML: A Real Life Observational Study (NILO-RED)
​December 2017, ASH2017

Exploratory study on the impact of switching to nilotinib in 18 patients with chronic myeloid leukemia in chronic phase with suboptimal response to imatinib
January 8, 2017, PubMed

Analysis of Adverse Events of Dasatinib and Nilotinib in Chronic Phase Chronic Myeloid Leukemia Patients Treated Outside Clinical Trials
​December 2016, ASH2016

Two-Year Consolidation By Nilotinib Is Associated with Successful Treatment Free Remission in Chronic Myeloid Leukemia with MR4.5:  Subgroup Analysis from STAT2 Trial in Japan
​December 2016, ASH2016
​
Cognitive dysfunction after withdrawal of tyrosine kinase inhibitor therapy in chronic myeloid leukaemia
July 28, 2016, American Journal of Hematology

Impact of Age on Efficacy and Toxicity of Nilotinib in Patients with Chronic Myeloid Leukemia in Chronic Phase (CML-CP): ENEST1st Sub-Analysis
December 7, 2015,  Blood Journal

Enestpath: A Phase III Study to Assess the Effect of Nilotinib Treatment Duration on Treatment-Free Remission (TFR) in Chronic Phase-Chronic Myeloid Leukemia (CP-CML) Patients (pts) Previously Treated with Imatinib: Interim Analysis from the First Year of Induction Phase
December 7, 2015,  Blood Journal
 
Treatment-Free Remission (TFR) Eligibility in Patients (pts) with Chronic Myeloid Leukemia in Chronic Phase (CML-CP) and Residual Disease on Long-Term Imatinib (IM) Who Switched to Second-Line Nilotinib (NIL)
December 7, 2015, Blood Journal

KIR2DL5B Associated With Poor Response in CML Treated With Sequential Imatinib, Nilotinib
October 26, 2015, Cancer Therapy Advisor

Long-Term Data Highlights Nilotinib Efficacy, Cardiovascular Effects
July 14, 2015, Cancer Network

Peripheral artery occlusive disease of the lower limbs: Rapid aggravation in a patient taking nilotinib for chronic myeloid leukemia
June 29, 2015, PubMed

Novel Imatinib/Nilotinib Strategy Could Optimize CML Treatment
March 17, 2015, Cancer Network

First- and Second-Line Nilotinib in CML
March 10, 2015, OncLive

Nilotinib plus chemotherapy pays off for older patients with Ph+ALL
December 9, 2014, The Oncology Report

Early onset hypercholesterolemia induced by the 2nd-generation tyrosine kinase inhibitor nilotinib in patients with chronic phase-chronic myeloid leukemia
July 2014, Haematologica

JAK2/STAT5 inhibition by nilotinib with ruxolitinib contributes to the elimination of chronic phase CML CD34+ cells in vitro and in vivo
June 16, 2014, Journal Blood

ENESTnd 5-year (y) update: Long-term outcomes of patients (pts) with chronic myeloid leukemia in chronic phase (CML-CP) treated with frontline nilotinib (NIL) versus imatinib (IM)
June 2,2014, 2014 ASCO Annual Meeting

Early molecular response predicts outcomes in patients with chronic myeloid leukemia in chronic phase treated with frontline nilotinib or imatinib
February 27, 2014, Blood
​
Mechanism of impaired glucose metabolism during nilotinib therapy in patients with chronic myelogenous leukemia
October 2013, Heamatologica

Nilotinib Associated With Increased Peripheral Artery Disease Rate in CML    WARNING
May 13, 2013, Cancer Network

TASIGNA® (nilotinib) - Possible Risk of Developing Atherosclerosis-Related Conditions - For the  Public
April  12, 2013, Health Canada

Bilateral renal artery stenosis in a patient with chronic myeloid leukemia treated with nilotinib
September 2012, Science Direct

Nilotinib in imatinib-resistant or imatinib-intolerant patients with chronic myeloid leukemia in chronic phase: 48-month follow-up results of a phase II study.
July 5, 2012,  PubMed

Concurrent use of proton pump inhibitors or H2 blockers did not adversely affect nilotinib efficacy in patients with chronic myeloid leukemia.
May 24, 2012, Unbound Medline

​Evaluation of residual CD34(+) Ph(+) progenitor cells  in chronic myeloid leukemia patients who have complete genetic response during first-line nilotinib therapy.
April 19, 2012,  PubMed

​Clinical cardiac safety profile of nilotinib.
January 22, 2012, PubMed

The Apothecary Shops Incorporates Innovative Technology Into Patient Medication Reminders
December 19, 2011, PRNewswire

Nilotinib in patients with Ph+ chronic myeloid leukemia in accelerated phase following imatinib resistance or intolerance: 24-month follow-up results.
November 11, 2011,  PubMed

Nilotinib Beats Imatinib at 24 Months in Treatment of CML
June 20, 2011, Medscape Today

Nilotinib Superior to Imatinib, Fewer Mutations in Treatment of CML-CP
June 6, 2011, Monthly Prescribing Reference

Nilotinib Attenuates Renal Injury and Prolongs Survival in Chronic Kidney Disease
November 13, 2010, JASN

Nilotinib versus Imatinib for Newly Diagnosed Chronic Myeloid Leukemia
June 5, 2010, The New England Journal of Medecine 

Novartis Tasigna® trial shows superior results to Glivec® in patients with early-stage chronic myeloid leukemia
December 9, 2009, Insciences organisation

Nilotinib for the frontline treatment of Ph+ chronic leukemia
December 3, 2009, Blood, Vol.114, No.24, pp.493304938

Effect of grapefruit juice on the pharmacokinetics of nilotinib in healthy participants
November 30, 2009, PubMed
 
Clinical pharmacokinetics of the BCR-ABL tyrosine kinase inhibitor nilotinib
November 18, 2009, PubMed
 
Effects of hepatic impairment on the pharmacokinetics of nilotinib: an open-label, single-dose, parallel-group study
November 15, 2009, PubMed

Targeted therapies for CML: practical considerations and comparisons
August 10, 2008, HemOncToday

​Nilotinib (formerly AMN107), a highly selective BCR-ABL tyrosine kinase inhibitor, is effective in patients with Philadelphia chromosome–positive chronic myelogenous leukemia in chronic phase following imatinib resistance and intolerance
November 15, 2007, Journal Blood

Nilotinib: a novel encouraging therapeutic option for chronic myeloid leukemia patients with imatinib resistance or intolerance
June 2007, NCBI

AMN107, a novel aminopyrimidine inhibitor of p190 Bcr-Abl activation and of in vitro proliferation of Philadelphia-positive acute lymphoblastic leukemia cells.
September 15, 2005, PubMed

New era drug gives hope to Gleevec® resistant leukaemia sufferers
April 19, 2005, News Medical
          
                  See also  the combination of Tasigna with Ruxolitinib (Jakavi)