Prescribing information



Start Tasigna when imatinib▼can’t deliver*


Patients with resistance or intolerance to previous therapy achieved optimal responses with Tasigna†1

Achieving optimal responses, as defined by the ELN,2 is associated with improved rates of both overall survival and progression-free survival.3–5

In the 2011 study, patients with Ph+ CML-CP who were resistant to or intolerant of imatinib were switched to Tasigna 400 mg twice daily.‡1


Chart showing the percentage of patients who had cytogenetic responses to treatment in second-line use



Response rate on Tasigna 400 mg twice daily in patients with a minimum of 24 months’ follow-up. Molecular response was evaluable in 294/321 patients.1


Real-world evidence from a retrospective, international audit showed that patients achieved deep and sustained responses after switching to Tasigna6


Comparable deep and sustained responses observed with second generation TKIs in second line regardless of dosing regimen6

Results from a retrospective observational analysis. p values are descriptive only.


Charts showing proportions of patients achieving molecular response 4.5 in the study or for at least 1 year


A retrospective chart review involving N=236 CML-CP patients treated in second line with nilotinib (n=115) or dasatinib (n=121). Due to the retrospective and observational nature of the study, results should be interpreted with caution. Any conclusions on efficacy between compounds cannot be drawn from this data and all p values generated in this study are descriptive only.


Charts showing adverse events causing discontinuation from imatinib, and recurrence or persistence of the event after switching to Tasigna


Switch to Tasigna for optimal responses‡‡5


* For intolerance or resistance to imatinib.8,9

Optimal as defined by the ELN 2020.2

In cases of treatment failure, as defined by the ELN 2020, patients should receive a different treatment to limit the risk of progression and death.2

§ After multivariate adjustment HR=1.36, 95% CI [1.01, 1.73], p<0.01. Not significant by univariate analysis p=0.46. p values are descriptive only.6

p=0.60. p values are descriptive only.6

** Patients with multiple reasons for imatinib intolerance are counted in each category.7

†† Number of imatinib-intolerant patients who experienced a Grade 3/4 AE during nilotinib therapy that was the same corresponding reason for imatinib intolerance.7

‡‡ In patients with resistance or intolerance to previous therapy.1

AE, adverse event; ALT, alanine transaminase; AST, aspartate transaminase; CCyR, complete cytogenetic response; CI, confidence interval; CML, chronic myeloid leukaemia; CP, chronic phase; ELN, European LeukemiaNet; HR, hazard ratio; IS, International Scale; MCyR, major cytogenetic response; MMR, major molecular response; MR4.5, molecular response 4.5; Ph+, Philadelphia chromosome positive; TKI, tyrosine kinase inhibitor.


  1. Kantarjian HM, et al. Blood. 2011;117(4):1141–1145.
  2. Hochhaus A, et al. Leukemia. 2020;34:966–984.
  3. Hochhaus A, et al. Leukemia. 2016;30(5):1044–1054.
  4. Marin D, et al. J Clin Oncol. 2012;30(3):232–238.
  5. Hanfstein B, et al. Leukemia. 2012;26(9):2096–2102.
  6. Cortes J, et al. Presented at the 22nd EHA Annual Congress 2017; 22–25 June, Madrid, Spain. Abstract PB1825.
  7. Cortes JE, et al. Blood. 2011;117(21):5600–5606.
  8. Tasigna® (nilotinib 200 mg and 50 mg) Summary of Product Characteristics. 2019.
  9. Tasigna® (nilotinib 150 mg) Summary of Product Characteristics. 2019.
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UK | May 2022 |205633

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Adverse events should be reported. Reporting forms and information can be found at Adverse events should also be reported to Novartis via [email protected] or online through the pharmacovigilance intake (PVI) tool at
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