announced 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."
About MOSAIC
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 eloxatin for more information about Eloxatin(R).
About Sanofi Aventis
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.
Sanofi Aventis
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