ASH Clinical News September 2015 | Page 9

AR TE
YEPDA

5U

99%

OF PATIENTS DID NOT PROGRESS TO AP/BC
AT 5 YEARS VS 95% WITH IMATINIB1*

*Based on Kaplan-Meier estimates of time to progression to AP or BC on core treatment (full analysis set) without clonal evolutions.
Estimated rates of no progression at 5 years: TASIGNA 99.3% (95% CI, 98.2%-100%) vs imatinib 95.2% (95% CI, 92.6%-97.9%).1

PROGRESSION EVENTS TO AP/BC1,2

2

TASIGNA PATIENTS
PROGRESSED TO AP/BC

12

IMATINIB PATIENTS
PROGRESSED TO AP/BC

DIAGNOSIS

6
MONTHS

12
MONTHS

18
MONTHS

24
MONTHS

3
YEARS

4
YEARS

5
YEARS

• No progressions to AP/BC occurred with TASIGNA after the first 6 months2

A HIGHER RATE OF MMR WAS ACHIEVED VS IMATINIB BY 5 YEARS1,2
• 77% of patients reached MMR by 5 years with TASIGNA (95% CI, 72%-82%) vs 60% with imatinib (95% CI, 55%-66%)1,2
• Median time on treatment was approximately 61 months in all treatment arms2
• The cumulative incidence of MMR end point by 5 years includes patients who achieved MMR at any time up to the 60-month cutoff. Subsequent loss
of MMR, patients who did not attain MMR, or those lost to follow-up are not included in this calculation1
FOR MORE INFORMATION AND ACCESS TO SAVINGS FOR ELIGIBLE PATIENTS, PLEASE VISIT WWW.TASIGNA.COM

IMPORTANT SAFETY CONSIDERATIONS
• Fluid Retention: Grade 3/4 fluid retention including pleural effusion, pericardial effusion, ascites and pulmonary edema have been reported in patients
receiving TASIGNA
• ADVERSE REACTIONS: The most commonly reported non-hematologic adverse reactions (≥20% in patients) were nausea, rash, headache, fatigue, pruritus,
vomiting, diarrhea, cough, constipation, arthralgia, nasopharyngitis, pyrexia, and night sweats. Hematologic adverse drug reactions include myelosuppression:
thrombocytopenia, neutropenia and anemia
• DOSE ADJUSTMENTS OR MODIFICATIONS: TASIGNA may need to be temporarily withheld and/or dose reduced for QT prolongation, hematologic toxicities that
are not related to underlying leukemia, clinically significant moderate or severe non-hematologic toxicities, laboratory abnormalities or concomitant use of strong
CYP3A4 inhibitors
References: 1. Data on file. Study no. CAMN107A2303. Novartis Pharmaceuticals Corp; 2014. 2. TASIGNA [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2015. 3. Larson RA, Hochhaus A, Hughes TP, et al.
Nilotinib vs imatinib in patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase: ENESTnd 3-year follow-up. Leukemia. 2012;26(10):2197-2203.

Novartis Pharmaceuticals Corporation
East Hanover, New Jersey 07936-1080

© 2015 Novartis

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