No new safety signals appeared while patients were on therapy in ENESTfreedom2
Hematologic AEs occurring on TKI therapy during TFR reported in ENESTfreedom
- No new major safety findings were observed at the 48-week analysis in patients treated with TASIGNA beyond those in the known safety profile of TASIGNA1
Musculoskeletal pain was reported early during the TFR phase and was generally low grade1
- Patients experienced musculoskeletal symptoms more frequently than before treatment discontinuation (eg, myalgia, pain in extremity, arthralgia, bone pain, spinal pain, or musculoskeletal pain)1
- Symptoms were transient, and none led to study discontinuation1
No progressions to AP/BC or CML-related deaths were reported on study1
Nonhematologic AEs occurring on TKI therapy during TFR reported in ENESTfreedom
aLipid metabolism events were not reported.2
cDefined as any of the following: musculoskeletal pain, myalgia, pain in extremity, arthralgia, bone pain, and/or spinal pain.2
ALT, alanine aminotransferase; AST, aspartate aminotransferase; ELN, European LeukemiaNet; TFR, treatment-free remission; NR, not reported.
- Hochhaus A, et al. ENESTfreedom Study. Leukemia [published online March 17, 2017]. 2017:1-7. doi:10.1038/leu.2017.63.
- Steegmann JL et al. Leukemia. 2016;30(8):1648-1671.