Optimal monitoring matters, whether on treatment or in TFR1-6

Frequent monitoring of molecular response is an important part of the Ph+ CML treatment and provides a level of assurance for physician and patient1

  • ELN recommends monitoring of patients on TKIs every 3 to 6 months using standardized PCR testing6
  • Close monitoring is an important requirement of TFR. Prompt reinitiation of therapy is necessary if a patient loses MMR or with confirmed loss of MR4.01

For eligible patients discontinuing TASIGNA:

  • Eligible patients who are confirmed to express the typical BCR-ABL transcripts, e13a2/b2a2 and/or e14a2/b3a2, can be considered for treatment discontinuation1
  • 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 transcript levels must be assessed prior to and during treatment discontinuation1
  • Monitor eligible patients every 3 months for 1 year, prior to discontinuation of therapy1
  • Counsel patients in TFR on the importance of close monitoring. Prompt re-initiation of therapy is necessary if a patient loses MMR or with confirmed loss of MR4.01,2
    • Upon the loss of MR4.0 during the treatment-free phase, BCR-ABL transcript levels should be monitored every 2 weeks until BCR-ABL levels return to a range between MR4.0 and MR4.5 or until BCR-ABL levels remain lower than MMR for 4 consecutive measurements1-3
  • In ENESTfreedom and ENESTop, nearly all patients who promptly re-initiated therapy with TASIGNA after loss of MMR or confirmed loss of MR4.0 were able to regain molecular response1-3

How often should a patient undergo molecular monitoring after reaching TFR?

  1. TASIGNA® (nilotinib) Summary of Product Characteristics. Basel, Switzerland: Novartis Pharma AG; May 2017.
  2. Hochhaus A, et al. ENESTfreedom Study. Leukemia [published online March 17, 2017]. 2017:1-7. doi:10.1038/leu.2017.63.
  3. Hughes TP, et al. ENESTop Study. ASCO; June 3-7, 2016; Chicago, Illinois. Poster 7054.
  4. Goldberg SL, et al. CMRO. 2013;29(9):1075-1082.
  5. Guerin A, et al. J Med Econ. 2014;17:89-98.
  6. Baccarani M, et al. Blood. 2013;122(6):872-884.