- Review Based on MOSAIC Clinical Trial Demonstrating Significantly
Improved Six-year Overall Survival in Stage III Colon Cancer Following
Surgery Compared to Standard Regimen Alone -
BRIDGEWATER, N.J., Feb. 20 /PRNewswire-FirstCall/ -- Sanofi-aventis
today announced that the U.S. Food and Drug Administration (FDA) has
accepted for filing and assigned priority review status to a supplemental
new drug application (sNDA) that proposes changes to the Eloxatin(R)
(oxaliplatin injection) prescribing information (PI) to include a six-year
analysis from the MOSAIC trial. In the proposed PI changes, sanofi-aventis
is seeking the inclusion of six-year overall survival and five-year disease
free survival data in Stage III colon cancer patients treated with either
FOLFOX4 (Eloxatin- based chemotherapy regimen) or standard infusional
5-FU/LV-based chemotherapy alone, following surgery to remove the primary
tumor.
A priority review designation sets the target date for the completion
of the FDA's review of the proposed changes at or before six months from
the date of filing.
"We are pleased that FDA is giving priority review to our application
for a label change to include updated six-year overall survival data," said
Dr. Nassir Habboubi, Vice President of U.S. Medical Affairs, Oncology, for
sanofi- aventis. "Inclusion of these data in the prescribing information
would provide physicians with a more updated analysis than the existing PI
and will help them better evaluate the use of prescribing an
Eloxatin(R)-based chemotherapy regimen for their Stage III colon cancer
patients."
In the MOSAIC trial, Stage III colon cancer patients treated after
complete surgical resection of the tumor with Eloxatin in combination with
infusional 5-FU/LV had a significant reduction (20%) in the risk of dying
after a median of six years compared to standard 5FU/LV-based chemotherapy
alone (hazard ratio of 0.80, confidence interval [0.65, 0.97], p=0.023).
Also, disease-free survival (risk of disease recurrence) was improved by
22% in Stage III patients (HR=0.78 [CI: 0.65, 0.93], p=0.005).
In the MOSAIC trial, the most frequently reported side effect was
neutropenia (decrease in the number of white blood cells), with 78.9% of
patients affected. Neutropenia was complicated by fever or infection in
only 1.8% of cases. 92.1% of patients treated with FOLFOX4 had peripheral
sensory neuropathy ("tingling or numbness" in the fingers or toes). Of
these events, 12% were severe (grades 3 and 4), and half (48.2%) of the
episodes were grade 1. Among patients experiencing grade 3 peripheral
sensory neuropathy, partial or total recovery was observed in most cases
within 18 months following treatment. Patients receiving FOLFOX4 also
reported nausea (73.7%), diarrhea (56.3%) and vomiting (47.2%).
Background on MOSAIC
The MOSAIC Study was conducted in 148 centers in 20 countries and
supported by sanofi-aventis. In this phase III randomized-controlled trial,
2,246 patients with Stage II or Stage III colon cancer whose tumor had been
completely surgically removed randomly received 5-FU/LV (n=1,123) or
FOLFOX4 (n=1,123) every two weeks for 12 cycles. The primary endpoint
evaluated how the addition of Eloxatin(R) affected disease-free survival at
three years. Secondary endpoints included overall survival and safety,
including long-term adverse effects. Based on the data from MOSAIC,
Eloxatin(R) in combination with infusional 5-FU/LV was granted U.S.
approval in 2004 for the treatment of Stage III colon cancer patients who
have their primary tumors surgically removed. At the time of the original
analysis, there was no demonstrated benefit in overall survival after a
median follow-up of four years.
About Colorectal Cancer
At Stage II, the cancer has grown through the wall of the colon or
rectum but has not yet spread to nearby lymph nodes. In 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.
Colorectal cancer is a leading cause of death. Every year, about one
million new cases of colorectal cancer are diagnosed worldwide. About
150,000 new cases are detected each year in the United States. 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. Over a lifetime, about 1 in 18 people develop colorectal cancer,
and more than 52,000 people are expected to die from it in the U.S. this
year.
Please see accompanying full prescribing information, including BOXED
WARNING, and visit http://www.eloxatin.com 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 PARIS: SAN) and in
New York (NYSE: SNY).
Contact: Noelle Boyd, sanofi-aventis, (908) 981-6489
SOURCE sanofi-aventis
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