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E/M Established Outpatient Visit

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2841. Bendamustine (Treanda)

Established Name bendamustine Trade Name Treanda ® Therapeutic Class Alkylating Agent Applicant Cephalon Priority Designation S Formulation I.V. Dosing Regimen 120 mg/m 2 , days 1 & 2, q 21 days Indication Rituximab-Refractory, Indolent NHL Intended Population Patients with indolent NHL Clinical Review, Division of Drug Oncology Products Virginia Kwitkowski NDA 22-303 /bendamustine (Treanda) 2 Table of Contents 1 Recommendations/Risk Benefit Analysis 10 1.1 Recommendation on Regulatory Action 10 1.2 Risk (...) -cell NHL who were rituximab-refractory. One-hundred patients were treated with bendamustine at a dose of 120 mg/m 2 IV over 60 minutes on days 1 & 2 every 21 days for 6-8 cycles. The Overall Response Rate (ORR) by the Independent Review Committee was 74% in this population with Complete Response (CR) and Complete Response unconfirmed (CRu) rates of 13% and 4% respectively. The median duration of response in this study was 9.2 months. Table 1: Primary Study Efficacy Data Efficacy Variable By IRC (N

2007 FDA - Drug Approval Package

2842. Multicentre randomised control trial comparing real time teledermatology with conventional outpatient dermatological care: societal cost-benefit analysis

Multicentre randomised control trial comparing real time teledermatology with conventional outpatient dermatological care: societal cost-benefit analysis Multicentre randomised control trial comparing real time teledermatology with conventional outpatient dermatological care: societal cost-benefit analysis Multicentre randomised control trial comparing real time teledermatology with conventional outpatient dermatological care: societal cost-benefit analysis Wootton R, Bloomer S E, Corbett R (...) , Eedy D J, Hicks N, Lotery H E, Mathews C, Paisley J, Steele K, Loane M A Record Status This is a critical abstract of an economic evaluation that meets the criteria for inclusion on NHS EED. Each abstract contains a brief summary of the methods, the results and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn. Health technology Real time teledermatology in general practice patients requiring referral to dermatology services. Standard

2000 NHS Economic Evaluation Database.

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