ASH Clinical News December 2015 | Page 67

AR TE
YEPDA

HELP RAISE THEIR RESPONSES TO THERAPY WITH TASIGNA

5U

FOR THE TREATMENT OF ADULTS WITH RESISTANT OR INTOLERANT Ph+ CML-CP/AP

PATIENTS SWITCHED FROM IMATINIB ACHIEVED RESPONSES
IN A SECOND-LINE STUDY2

51%
39%

OF Ph+ CML-CP PATIENTS

ACHIEVED MCyR

(UNCONFIRMED)

(n=321; 95% CI, 46%-57%)2

OF Ph+ CML-AP PATIENTS

ACHIEVED HR

(CONFIRMED)

(n=137; 95% CI, 31%-48%)2

DID YOU
KNOW?

• 37% of imatinib-resistant or -intolerant patients with Ph+ CML-CP
achieved complete cytogenetic response with TASIGNA (95% Cl, 32%-42%)2
• 15% of imatinib-resistant or -intolerant patients with Ph+ CML-CP achieved
partial cytogenetic response with TASIGNA (95% Cl, 11%-19%)2
• 321 Ph+ CML-CP patients with prior imatinib use were treated with TASIGNA
400 mg bid for a median duration of 18.4 months2
• 2.8 months median time to MCyR among responders (range 1-28 months)2
• 30% of imatinib-resistant or -intolerant patients with Ph+ CML-AP reached
CHR (95% CI, 22%-38%), while 9% (95% CI, 5%-16%) attained NEL2
• 1 month median time to HR among responders (range 1-14 months)2

SWITCHING TO TASIGNA CAN HELP
GET PATIENTS CLOSER TO THEIR GOALS

Kareem Abdul-Jabbar is an actual Ph+ CML patient taking TASIGNA and was previously treated with imatinib.
Second-line study design: A single-arm, open-label, multicenter study in 321 patients with imatinib-resistant or -intolerant Ph+ CML-CP and 137 patients with Ph+ CML-AP. Patients received TASIGNA 400 mg bid for a minimum
follow-up of 24 months. The definition of imatinib resistance included failure to achieve complete hematologic response ([CHR] by 3 months), cytogenetic response (by 6 months), or major cytogenetic response ([MCyR] by 12 months) or
progression of disease after a previous cytogenetic or hematologic response. Imatinib intolerance was defined as discontinuation of treatment due to toxicity and lack of MCyR at time of study entry. The efficacy end point in CML-CP was
unconfirmed MCyR, which included complete and partial cytogenetic responses. The efficacy end point in CML-AP was confirmed hematologic response (HR), defined as either a CHR or no evidence of leukemia (NEL).2

FOR MORE INFORMATION AND ACCESS TO SAVINGS FOR ELIGIBLE PATIENTS, PLEASE VISIT WWW.TASIGNA.COM

IMPORTANT SAFETY CONSIDERATIONS
• Monitoring Laboratory Tests: Chemistry panels, including electrolytes, calcium, magnesium, lipid profile, liver enzymes, and glucose should be
checked prior to therapy and periodically
• Embryo-Fetal Toxicity: Women of childbearing potential should avoid becoming pregnant while taking TASIGNA and should be advised of the potential
hazard to the fetus if they do
• 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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