- FDA Approval Based on Updated Results Showing a 20% Reduction in the Risk of Death at Six Years and a 22% Improvement of Disease Free Survival at
Five Years, For Stage III Colon Cancer, Post Surgery -
BRIDGEWATER, N.J., May 28 /PRNewswire-FirstCall/ -- Sanofi-aventis U.S. announced today that the U.S. Food and Drug Administration (FDA) approved the supplemental new drug application (sNDA) to include six-year overall survival analysis from the MOSAIC trial in the Eloxatin(R) (oxaliplatin injection) prescribing information (PI). The new PI also reports five-year disease free survival (DFS) data in Stage III colon cancer patients treated following surgery to remove the primary tumor.
The MOSAIC trial results showed that after a median follow-up of six years, Stage III colon cancer patients treated with FOLFOX4 had a 20 percent reduction in the risk of dying compared to those treated with standard chemotherapy alone (hazard ratio of 0.80, confidence interval [0.65, 0.97] p=0.023). Stratified log-rank test was not adjusted for multiple comparisons. Also, Stage III patients treated with the Eloxatin-based regimen at 5 years were 22 percent less likely to relapse or risk of disease recurrence (HR=0.78 [CI: 0.65, 0.93], p =0.005) after 77 month follow-up.
"The MOSAIC six-year follow-up data demonstrate that as an adjuvant treatment for Stage III colon cancer, the Eloxatin-based regimen significantly lowered the risk of death and recurrence," said principal investigator Aimery de Gramont, MD, Oncology, Hospital Saint Antoine, Paris, France.
In the MOSAIC trial, neutropenia (decrease in the number of white blood cells) was the most frequently reported side effect, affecting 78.9% of patients. Neutropenia was complicated by fever or infection in only 1.8% of cases. Peripheral sensory neuropathy ("tingling or numbness" in the fingers or toes) occurred in 92.1% of patients treated with FOLFOX4. Half (48.2%) of the episodes were grade 1, and 12% were severe (grades 3 and 4). Partial or total recovery was observed within 18 months following treatment in most patients experiencing grade 3 peripheral sensory neuropathy. Patients treated with FOLFOX4 also reported nausea (73.7%), diarrhea (56.3%) and vomiting (47.2%).
"This announcement is welcome news for patients who have a significantly higher chance of surviving Stage III colon cancer when treated with the Eloxatin-based regimen following surgery," noted Dr. de Gramont. "Inclusion of these survival results in the new U.S. Eloxatin PI marks an important milestone in the treatment of colon cancer."
Eloxatin(R) in combination with infusional 5-FU/LV was first granted U.S. approval in 2004 for the treatment of Stage III colon cancer patients who have their primary tumors surgically removed based on the disease-free survival data from MOSAIC after a median follow-up of three years. At the time of the original analysis, there was no demonstrated benefit in overall survival after a median follow-up of four years.
Supported by sanofi-aventis, the phase III controlled MOSAIC trial was conducted in 148 centers in 20 countries. In MOSAIC, 2,246 patients with Stage II or Stage III colon cancer whose tumor had been completely surgically removed were randomized to treatment with either the Eloxatin-based FOLFOX4 regimen (n=1,123) or standard chemotherapy 5-FU/LV (n=1,123) every two weeks for 12 cycles. The primary endpoint evaluated how the addition of Eloxatin affected disease-free survival at three years. Secondary endpoints included overall survival and safety, including long-term adverse effects.
About Colorectal Cancer
Stage II colorectal cancer indicates that the cancer has grown through the wall of the colon or rectum but has not yet spread to nearby lymph nodes. At Stage III, the cancer has invaded one or more of the local lymph nodes but has not spread to distant sites. Metastatic colorectal cancer means that the cancer has spread to other nodes and/or organs in the body.
About 150,000 new cases are detected each year in the United States. Over a lifetime, about 1 in 19 people develop colorectal cancer, and more than 49,960 people are expected to die from it in the U.S. this year. According to the American Cancer Society, colorectal cancer is the third leading cause of cancer-related death in the U.S., accounting for about 10% of all cancer deaths.
Please see accompanying full prescribing information, including BOXED WARNING, and visit http://www.eloxatin.com for more information about Eloxatin(R).
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Forward Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include financial projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future events, operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans" and similar expressions. Although sanofi-aventis' management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in sanofi-aventis' annual report on Form 20-F for the year ended December 31, 2007. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.
Contact: Stephanie Stamatakou, sanofi-aventis, (908) 981-6127
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