Prescribing information

 

 

Start with Tasigna to help achieve long-term treatment success1,2

Image with the words 'the journey starts with Tasigna'

 

For the treatment of Philadelphia chromosome positive chronic myelogenous leukaemia (Ph+ CML).1,2

Indication

Tasigna is indicated for the treatment of:

  • Adult and paediatric patients with newly diagnosed Ph+ CML in the chronic phase
  • Adult patients with chronic phase and accelerated phase Ph+ CML with resistance or intolerance to prior therapy including imatinib▼. Efficacy data in patients with CML in blast crisis are not available
  • Paediatric patients with Ph+ CML in chronic phase with resistance or intolerance to prior therapy including imatinib1,2
 

What is Tasigna?

Tasigna is an oral, twice-daily potent inhibitor of the ABL tyrosine kinase activity of the BCR-ABL oncoprotein. In cell lines and in primary Ph+ leukaemia cells Tasigna selectively inhibits proliferation and induces apoptosis.1,2

  • In the ENESTnd study, patients treated with Tasigna experienced higher response rates than those treated with imatinib, and Tasigna demonstrated superior efficacy vs imatinib3–5
  • In a post hoc analysis more patients achieved early molecular response* with Tasigna than imatinib, a predictor of long-term benefits6,7
  • More than half of patients achieved MR4.5 by 5 years with Tasigna vs a third treated first line with imatinib1,2,8
  • >99% of all patients treated with Tasigna did not progress to AP/BC†8
  • In patients who achieved sustained MR4.5 on Tasigna and entered TFR, more than 50% remained in TFR1,2
  • Tasigna has a well-established tolerability and consistent safety profile1,2,9

 

 

* EMR is defined as BCR-ABL1 ≤10% at 3 months.9

In patients who remained on core treatment during the ENESTnd study.8

AP, accelerated phase; BC, blast crisis; CML, chronic myeloid leukaemia; CP, chronic phase; EMR, early molecular response; ENESTnd, Evaluating Nilotinib Efficacy and Safety in Clinical Trials–Newly Diagnosed Patients; MR4.5, molecular response 4.5; Ph+, Philadelphia chromosome positive; TFR, treatment-free remission.

References

  1. Tasigna® (nilotinib 200 mg and 50 mg) Summary of Product Characteristics. 2019.
  2. Tasigna® (nilotinib 150 mg) Summary of Product Characteristics. 2019.
  3. Saglio G, et al. N Engl J Med. 2010;362(24):2251–2259.
  4. Kantarjian HM, et al. Lancet Oncol. 2011;12(9):841–851.
  5. Larson RA, et al. Leukemia. 2012;26(1):2197–2203.
  6. Hughes TP, et al. Blood. 2014;123(9):1353–1360.
  7. Marin D, et al. J Clin Oncol. 2012;30(3):232–238.
  8. Hochhaus A, et al. Leukemia. 2016;30(5):1044–1054.
  9. Larson RA, et al. Blood. 2014;124(21):4541.
HCP20-C028 June 2020.
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Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk. Adverse events should also be reported to Novartis via [email protected] or online through the patient safety information (PSI) tool at https://psi.novartis.com
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