Pharmacy & Therapeutics - February 2009 - (Page 57)

For chronic lymphocytic leukemia (CLL)—T R E A N D A ® Break away from expectations Dual structure TREANDA is a unique treatment that combines an alkylating group with a purine-like benzimidazole ring 1,2 Anti-tumor activity The exact mechanism of action of TREANDA remains unknown Dual cell-death effects via several pathways1,3-5 –Preclinical studies suggest that TREANDA may cause both apoptotic and nonapoptotic death of malignant cells –TREANDA is active against both quiescent and dividing cells Superior clinical performance TREANDA tripled progression-free survival (PFS) and more than doubled overall response rate (ORR) vs chlorambucil SUPERIOR PFS 1.0 0.9 Survival distribution function TREANDA vs chlorambucil 59% ORR with TREANDA (95% CI: 51.03, 66.62) vs 26% (95% CI: 18.64, 32.71) (P<.0001) –Complete response 8% vs <1% Median duration of response 19 mo with TREANDA (95% CI: 15.0, 24.2) vs 7 mo (95% CI: 5.8, 10.4)1 Median PFS 18 mo with TREANDA (95% CI: 11.7, 23.5) vs 6 mo (95% CI: 5.6, 8.6) The efﬁcacy and safety of TREANDA were assessed compared with chlorambucil in a randomized, open-label, multicenter, Phase 3 trial in treatment-naïve patients with Binet stage B or C (Rai stages I-IV) CLL who required treatment (N=301). Patients were randomized to receive either single-agent TREANDA 100 mg/m2 IV on Days 1 and 2 (n=153) or single-agent chlorambucil 0.8 mg/kg PO on Days 1 and 15 (n=148), up to six 28-day cycles.1 0.8 0.7 0.6 0.5 0.4 0.3 0.2 0.1 0 5 10 15 20 Months 25 risk reduction* 73% TREANDA (n=153) (n=148) Chlorambucil P<.0001 HR†=0.27 (95% CI†: 0.17, 0.43) 30 35 40 45 *Reduction in risk of progression of disease or death from any cause. † HR=hazard ratio; CI=conﬁdence interval. Observed side-effect proﬁle The most common non-hematologic adverse reactions (frequency ≥15%) are pyrexia (24%), nausea (20%), and vomiting (16%). The most common hematologic abnormalities (frequency ≥15%) are anemia (89%), thrombocytopenia (77%), neutropenia (75%), lymphopenia (68%), and leukopenia (61%). TREANDA is indicated for the treatment of patients with CLL. Efﬁcacy relative to ﬁrst-line therapies other than chlorambucil has not been established. Please see accompanying brief summary of Prescribing Information, including references. ©2008 Cephalon, Inc. All rights reserved. TRE210 November 2008 Built for Action www.TREANDA.com http://www.TREANDA.com

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Pharmacy & Therapeutics - February 2009 Contents Editorial Medication Errors Prescription: Washington New Drugs/Drug News/New Medical Devices Drug Forecast Pushing an Expanded Role for Pharmacists Better Asthma Management with Advanced Technology Pharmaceutical Approval Update 58th Annual Meeting, American Society of Human Genetics, 2008 American Society of Hematology, 50th Annual Meeting and Exposition 2008 San Antonio Breast Cancer Symposium Stahl’s Essential Psychopharmacology, 3rd Edition Author Guidelines

Pharmacy & Therapeutics - February 2009

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