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