BioHorizon » carcinoma http://www.biohorizon.com Emerging Health Technology Surveillance and Analysis Wed, 26 Oct 2011 17:27:01 +0000 en hourly 1 http://wordpress.org/?v=3.0 Sanofi-Synthelabo’s Eloxatin for Postsurgical Treatment of Stage III Colon Cancer http://www.biohorizon.com/2004/11/sanofi-synthelabo%e2%80%99s-eloxatin-for-postsurgical-treatment-of-stage-iii-colon-cancer/ http://www.biohorizon.com/2004/11/sanofi-synthelabo%e2%80%99s-eloxatin-for-postsurgical-treatment-of-stage-iii-colon-cancer/#comments Fri, 05 Nov 2004 18:46:41 +0000 admin http://www.biohorizon.com/?p=172 On November 5, 2004 Sanofi-Synthelabo’s Eloxatin™ (oxaliplatin for injection) received US FDA approval for use in combination with conventional chemotherapy (5-flurouracil and leukovorin) for the postsurgical treatment of stage III colon cancer patients. According to the company, this is the first new chemotherapy approval for the adjuvant treatment of colon cancer in over a decade. Approval for this new indication was based on the MOSAIC study, an international Phase 3 clinical trial enrolling over 2000 patients. According to the company there was a statistically significant improvement in the primary end point of disease free survival at a median follow-up of 4 years compared with infusional 5-FU/LV. The company concluded that these results demonstrated that the addition of Eloxatin to conventional adjuvant chemotherapy for colon cancer (5-FU/LV) reduced the risk of recurrence of cancer by 24% in the overall patient population who had undergone surgery to remove their primary tumor. Based on the FDA’s ruling, BioHorizon assigns a score of 100/100 to Eloxatin for efficacy.

Eloxatin was first approved in the US in January 2004 for the first-line treatment of advanced carcinoma of the colon or rectum in combination with infusional 5-FU/LV. In August 2002, this combination received approval for second-line treatment of this patient population (i.e., therapy for already treated patients with metastatic colorectal cancer). Oxaliplatin is a third-generation platinum derivative currently marketed by Sanofi-Aventis in more than 60 countries for the treatment of metastatic colorectal cancer. BioHorizon has assigned this emerging chemotherapy agent 65 points for innovation.

American Cancer Society estimates that 106,370 new cases of colon cancer will be diagnosed in the United States in 2004. This represents an incidence of 37/100,000 Americans and results in a burden of illness score of 18. Standard care for most colon cancer patients is surgical resection; however, a significant number of these patients will be candidates for adjuvant chemotherapy regimens designed to reduce the risk of the cancer’s recurrence and/or spread. Demand/diffusion will depend upon the extent to which oncologists integrate Eloxatin into adjuvant regimens. According to company news releases, global sales of Eloxatin rose 54.5 percent to 873 million euros ($1.1 billion) in the first nine months of 2004. Eloxatin earns a demand/diffusion score of 50.

Eloxatin receives a Moderate/High Score of 58. We are recommending commencement of assessment activities as soon as possible. Clients are advised to consult with key prescribing oncologists while reviewing the clinical epidemiology of colorectal
cancer.

Technology Details
Target Disease / Indication: Colorectal Cancer
Technology Classification: Drug
Body System: Gastrointestinal System
Program Area: Medicine/Oncology
Regulatory Status: Approved
BioHorizon Impact Score: 58/100 – Moderate/High

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