tasigna.com
Chronic Myeloid Leukaemia (CML) Molecular Response 4.5
http://www.tasigna.com/deep_molecular_response.html
This site is intended for Healthcare Professionals outside the U.S. Summary of Product Characteristics. MR45 Has Significant Clinical Implications for Patients With CML. Molecular response with a 4.5-log reduction in BCR-ABL transcripts from baseline (MR4.5) is the first molecular marker shown to have greater prognostic value than 0.1% to 1% on the International Scale (IS), which corresponds to a complete cytogenetic response (CCyR). Progression according to response level. 2015 Novartis A.G.
tasigna.com
Tasigna (nilotinib) Side Effects and Safety
http://www.tasigna.com/enest_nd_safety_data.html
This site is intended for Healthcare Professionals outside the U.S. Summary of Product Characteristics. TASIGNA Has Manageable Tolerability in Patients with Ph CML-CP. In ENESTnd, 12.1% of patients taking TASIGNA discontinued therapy by 5 years due to adverse events vs 13.4% of those taking imatinib. The median time on treatment was 60.5 months (range 0.1 - 70.8 months). All Grade, %. Skin and subcutaneus tissue. Metabolism and Nutrition Disorders. Grade 3 or 4, %. 2015 Novartis A.G.
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Tasigna (nilotinib) and Deeper Molecular Response
http://www.tasigna.com/deeper_responses.html
This site is intended for Healthcare Professionals outside the U.S. Summary of Product Characteristics. More Patients Achieved MMR With TASIGNA (nilotinib) vs Imatinib. In ENESTnd, assessment of the rates of MMR showed twice as many patients achieved MMR by 12 months. With TASIGNA vs imatinib. Cumulative Rate of MMR by 5 Years in ENESTnd. Percent of Patients With MMR by 1 Year in ENESTnd. In ENESTnd, MMR rates remained higher. By 5 years with TASIGNA vs imatinib. By 5 years compared with imatinib.
tasigna.com
CML Major Molecular Reponse
http://www.tasigna.com/major_molecular_response.html
This site is intended for Healthcare Professionals outside the U.S. Summary of Product Characteristics. MMR Has Significant Prognostic Value for Patients With CML. Achievement of MMR is associated with higher rates of EFS. Durable MMR is associated with improved PFS. 7-year EFS according to molecular response at 12 months. Achieving MMR is associated with improved clinical outcomes. Cytogenetic testing lacks the sensitivity to identify MMR achievement. Radich JP. Blood. 2009;114(16):3376-3381;.
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Progression with Tasigna (nilotinib)
http://www.tasigna.com/fewer_progressions.html
This site is intended for Healthcare Professionals outside the U.S. Summary of Product Characteristics. Fewer Patients Progressed With TASIGNA (nilotinib) vs Imatinib. With 5 years of follow-up on ENESTnd, treatment with TASIGNA resulted in fewer progressions vs imatinib. No patient with MR4.5 in any arm progressed. 99% of patients treated with TASIGNA 300 mg BID. Remained In Chronic Phase at 5 Years (n = 282). In patients still receiving study treatment. Larson RA, et al. JCO. Larson RA, et al. JCO.
tasigna.com
Chronic Myeloid Leukaemia Overview
http://www.tasigna.com/ph_cml_overview.html
This site is intended for Healthcare Professionals outside the U.S. Summary of Product Characteristics. Ph CML Disease Overview. Philadelphia chromosome-positive chronic myeloid leukemia (Ph CML) is a disease caused by an abnormal fusion protein, BCR-ABL. Ph CML is a myeloproliferative disease characterized by the presence of the abnormal Philadelphia chromosome in hematopoietic stem cells. The Philadelphia chromosome results from a reciprocal translocation of sections of chromosomes 9 and 22. ENESTnd is...
tasigna.com
Early Molecular Response (EMR) vs Imatinib | Tasigna (nilotinib)
http://www.tasigna.com/earlier_responses.html
This site is intended for Healthcare Professionals outside the U.S. Summary of Product Characteristics. More Patients Achieved Early Molecular Response With TASIGNA (nilotinib) vs Imatinib. ELN has defined optimal response milestones in newly diagnosed patients with Ph CML-CP. At 3 months the recommended optimal response is BCR-ABL. 10%, also referred to as EMR. In retrospective analysis of ENESTnd evaluating EMR at 3 months, more patients achieved EMR with TASIGNA. In patients on TASIGNA or imatinib.
tasigna.com
IS BCR ABL and CML Prognosis
http://www.tasigna.com/early_molecular_response.html
This site is intended for Healthcare Professionals outside the U.S. Summary of Product Characteristics. Achieving 10% IS BCR-ABL* Is Prognostic for Long-Term Survival in CML. Achievement of 10% International Scale (IS) BCR-ABL at 3 months significantly predicted overall survival (OS) at 8 years. Patients with BCR-ABL transcript levels 10% IS at 3 months had significantly lower OS than those with 10% IS. 8-year OS according to 10% IS BCR-ABL at 3 months. Or on the U.S. Residents link on this page.
tasigna.com
Chronic Myeloid Leukaemia (CML) ELN Treatment Guidelines
http://www.tasigna.com/eln_recommendations.html
This site is intended for Healthcare Professionals outside the U.S. Summary of Product Characteristics. Monitoring CML Treatment Response. For patients receiving long-term therapy for Philadephia chromosome-positive chronic myeloid leukemia (Ph CML), ongoing monitoring is needed to assess whether they have achieved or are making progress toward a desired response to therapy and to ensure that their treatment is optimized over time. At least 20 meta phases must be counted. Measures BCR-ABL transcript leve...
