Prescribing information

 

   

The journey to long-term disease control starts with Tasigna1,2

 

2. Diagram showing how different therapeutic goals can be used to assess response to Tasgina in newly diagnosed or treatment-refractory patients

 

ELN 2020 guidelines

Since the 2013 guidelines, treatment for CML has changed significantly. Therapeutic goals now include achieving normal life expectancy, as well as stable and deep molecular responses. In acknowledgement of this, the ELN has issued updated recommendations.7 

Milestones for treating CML7

Expressed as BCR-ABL1 on the IS

  Optimal Warning Failure
Baseline NA High-risk ACA, high-risk ELTS score NA
3 months ≤10% >10% >10% if confirmed within 1–3 months
6 months ≤1% >1–10% >10%
12 months ≤0.1% >0.1–1% >1%
Any time ≤0.1% >0.1–1%, loss of ≤0.1% (MMR) >1%, resistance mutations, high-risk ACA

Patients are eligible for TFR after a minimum of 3 years of Tasigna treatment with a sustained deep molecular response for a minimum of 1 year immediately prior to discontinuation of therapy. It is critical to continue frequent and regular monitoring according to on-label criteria.† Patients who lose MMR, or MR4.0 for patients previously treated with imatinib, must reinitiate Tasigna treatment within 4 weeks with continuous monitoring until MMR has been re-established.‡1,2

 

Start Tasigna for newly diagnosed patients

Optimal responses

  • More patients achieved optimal responses as defined by the ELN with Tasigna vs imatinib3,8,9

Deep responses

  • ENEST1st demonstrated that Tasigna can deliver deep molecular responses, defined as ≤0.01% BCR-ABL IS (MR4 or better)6
  • Cumulative incidence of MR4 by 24 months was 55.2% (581/1052)6
  • Cumulative incidence of MR4.5 by 24 months was 38.6% (406/1052)6

Long-term responses

  • More than half of patients treated with Tasigna achieved MR4.5 by 5 years1,2,6
  • >99% of patients who achieved MR4.5 with Tasigna DID NOT PROGRESS to AP/BC at any point during study treatment (280 of 282 patients)6

Start Tasigna for the possibility of TFR

In CML-CP patients who had achieved MR4.5 with Tasigna as first-line therapy:

  • 52% (98/190; 95% CI: 44.2–58.9) of patients remained in TFR at 48 weeks after discontinuing Tasigna§ with no loss of MMR10

Start Tasigna when imatinib can’t deliver

  • Patients with resistance or intolerance to previous therapy achieved optimal responses with Tasigna5
  • Low incidence of cross-intolerance with Tasigna in patients who are intolerant to imatinib11

Patients in a real-world setting achieved optimal and deep molecular responses with Tasigna

UK TARGET CML study:¶12

  • Retrospective, observational study
  • 21 NHS secondary/tertiary care centres across the UK
  • 257 patients enrolled
  • ≥13 months follow-up

With a median overall follow-up of 33 months (range 13–57), 113/257 (44%) of patients switched TKI at least once (54 [21%] switched more than once).

Second-line: patients on second-line Tasigna and with a minimum of 13 months’ follow-up by data cut-off:**12

 

 

 

An optimal response (MMR by 12 months) in patients on Tasigna second line was observed in:

 Pie chart showing optimal responses to Tasigna in the second-line setting

 

 

A deep response of MR4 or better (at any time) was observed in:

 Pie chart showing deep responses to Tasigna in the second-line setting
 

 

The UK TARGET study provides real-world evidence of patients achieving optimal and deep responses in first and second line.12

 

Choose Tasigna for wherever your patients need to go

 

* After a median observation of 3 years.4

Frequent monitoring of BCR-ABL transcript levels in patients eligible for treatment discontinuation must be performed with a quantitative diagnostic test validated to measure molecular response levels with a sensitivity of at least MR4.5 (BCR-ABL/ABL ≤0.0032% IS). BCR-ABL transcript levels must be assessed prior to and during treatment discontinuation.1,2

Loss of major molecular response (MMR=BCR-ABL/ABL ≤0.1% IS) in CML patients who received nilotinib as first- or second-line therapy, or confirmed loss of MR4 (two consecutive measures separated by at least 4 weeks showing loss of MR4 (MR4=BCR-ABL/ABL ≤0.01% IS)) in CML patients who received nilotinib as second-line therapy will trigger treatment reinitiation within 4 weeks of when loss of remission is known to have occurred. Molecular relapse can occur during the treatment-free phase, and long-term outcome data are not yet available. It is therefore crucial to perform frequent monitoring of BCR-ABL transcript levels and complete blood count with differential in order to detect possible loss of remission. For patients who fail to achieve MMR after three months of treatment reinitiation, BCR-ABL kinase domain mutation testing should be performed.1

§ As the prespecified statistical null hypothesis (TFR rate ≤50%) could not be rejected because of the lower limit of the 95% CI being ≤50%, the primary endpoint was not met.10

UK TARGET CML is an observational retrospective chart review where descriptive statistics only were applied. Responses shown were observed in this real-world cohort; firm conclusion on compound efficacy cannot be drawn from these results. UK TARGET CML is an ongoing study conducted at 21 NHS secondary/tertiary care centres across the UK.12

** Denominator is number of patients on second line with ≥13 months’ available follow-up from start of second TKI to date of data collection or date of switch (if patient did not stay on second line).12

ACA, additional cytogenetic abnormalities; AP, accelerated phase; BC, blast crisis; CCyR, complete cytogenetic response; CI, confidence interval; CML, chronic myeloid leukaemia; CP, chronic phase; ELN, European LeukemiaNet; ELTS, EUTOS Long Term Survival; EMR, early molecular response; ENEST, Evaluating Nilotinib Efficacy and Safety in Clinical Trials; IS, International Scale; MMR, major molecular response; MR4, molecular response 4; MR4.5, molecular response 4.5; Ph+, Philadelphia chromosome positive; TFR, treatment-free remission; TKI, tyrosine kinase inhibitor.

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. Baccarani M, et al. Blood. 2013;122(6):872–884.
  4. Hehlmann R, et al. J Clin Oncol. 2014;32(5):415–423.
  5. Kantarjian HM, et al. Blood. 2011;117(4):1141–1145.
  6. Hochhaus A, et al. Leukemia. 2016;30(1);57–64.
  7. Hochhaus A, et al. Leukemia. 2020;34:966–984.
  8. Hughes TP, et al. Blood. 2014;123(9):1353–1360.
  9. Saglio G, et al. N Engl J Med. 2010;362(24):2251–2259.
  10. Hochhaus A, et al. Leukemia. 2017;31(7):1525–1531.
  11. Cortes JE, et al. Blood. 2011;117(21):5600–5606.
  12. Milojkovic D, et al. Presented at the 24th EHA Annual Meeting 2019; 13–16 June, Amsterdam, The Netherlands. Poster PS1182.
HCP20-C028a June 2020.
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