FDA grants priority
review to ELOXATIN®
for the 1st line treatment of metastatic colorectal cancer
SANOFI-SYNTHELABO announced today
that the U.S. Food and Drug Administration (FDA) has granted a six-month priority review
to ELOXATIN® (oxaliplatin), for the 1st line treatment of
metastatic colorectal cancer (MCRC).
The supplemental New Drug Application
(sNDA) for ELOXATIN® in this indication had been submitted on July 11, 2003
in the United States.
The filing for this new indication
was based on a NCI-sponsored trial, N 9741. The trial was coordinated by the North Central
Cancer Treatment Group (NCCTG). Patients receiving the FOLFOX regimen (oxaliplatin +
5-FU/LV) versus the IFL regimen (irinotecan + 5-FU/LV), have a statistically significant
improvement in terms of response rate (RR), progression free survival (PFS), overall
survival (OS) and safety profile. The overall survival was 19.5 months with the FOLFOX
regimen versus 14.8 months with the IFL regimen (p = 0.0001) giving an improvement of 4.7
months in favor of oxaliplatin-based treatment, representing a survival gain of more than
30%.
Further development in
colorectal cancer
In addition to these important
results, new data were also presented at the 39th annual meeting of the American Society
of Clinical Oncology (ASCO), in June 2003, in adjuvant treatment following surgery, the
early stage of the disease — MOSAIC study. In patients receiving oxaliplatin in
addition to the current post surgery standard chemotherapy, 5-Fluorouracil/Leucovorin
(5-FU/LV), for colon cancer the risk of recurrence was reduced by 23% vs. current standard
treatment alone. The filing in the United States and in Europe for the adjuvant treatment
of colorectal cancer should occur in the second half of the year 2003.
About Colorectal Cancer
About one million new cases of
colorectal cancer are diagnosed worldwide every year, and about 150,000 new cases in the
U.S. According to the American Cancer Society, colorectal cancer is the second leading
cause of malignancy-related death in the U.S., accounting for 10 to 15% of all cancer
death. Over a lifetime, about one in 18 people develop colorectal cancer, and, each year,
about 56,000 people die from it in the U.S.
About Eloxatin®
ELOXATIN® is currently
marketed by Sanofi-Synthelabo in more than 60 countries for 1st and/or 2nd line metastatic
colorectal cancer and is becoming a cornerstone drug in the therapeutic strategies for all
stages of this disease, including early stages. Moreover an extensive worldwide clinical
development program is ongoing to explore the benefit of ELOXATIN® in other
types of cancers, primarily gastric and pancreatic cancer.
Global sales of
ELOXATIN® for the first semester 2003 reached EUR 384 million. Oxaliplatin
was developed in association with Debiopharm S.A.
About Eloxatin® in
the United States
In the US, ELOXATIN®
(oxaliplatin for injection) is approved for use in combination with infusional
5-fluorouracil (5-FU) and leucovorin (LV), and is currently indicated for the treatment of
patients with metastatic carcinoma of the colon or rectum whose disease has recurred or
progressed during or within six months of completion of first-line therapy with the
combination of bolus 5-FU/LV and irinotecan. The approval of ELOXATIN® was
based on the response rate and time to tumor progression observed in an ongoing trial.
Data that demonstrate a clinical benefit, such as improvement of disease-related symptoms
or increased survival were not available at approval.
ELOXATIN® is a
chemotherapeutic cancer agent and as such should be administered under the supervision of
a qualified physician experienced in the use of such products.
ELOXATIN® should not
be administered to patients with a history of known allergy to ELOXATIN® or
other platinum compounds. Women of childbearing potential should be advised not to become
pregnant while receiving treatment with ELOXATIN®. As with other platinum
compounds, hypersensitivity and anaphylactic/anaphylactoid reactions have been reported.
ELOXATIN® is associated with pulmonary toxicity, which may be fatal and two
distinct types of primarily peripheral sensory neuropathies: an acute, reversible type of
early onset and a persistent type (>14 days). An acute syndrome of pharyngolaryngeal
dysesthesia seen in 1-2% of patients characterized by subjective sensations of dysphagia
or dyspnea, without any laryngospasm or bronchospasm (no stridor or wheezing) may also
occur.
Both 5-FU and
ELOXATIN® are associated with gastrointestinal and hematologic adverse
events. When ELOXATIN® is administered in combination with 5-FU, the
incidence of these events is increased. The most frequently reported adverse events with
ELOXATIN® in combination with infusional 5-FU/LV are acute neuropathy
(56%), persistent neuropathy (48%), fatigue (68%), diarrhea (67%), nausea (65%) and
vomiting (40%). Changes in hematology parameters were also seen: anemia (81%), leukopenia
(76%), neutropenia (73%), and thrombocytopenia (64%).
Full prescribing information
including boxed warning is available through www.eloxatin.com.
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This release contains statements
that constitute forward-looking statements within the meaning of the U.S. Private
Securities Litigation Reform Act of 1995. These statements are based on management’s
current expectations or beliefs and are subject to a number of factors and uncertainties
that could cause actual results to differ materially from those described in the
forward-looking statements. The following factors, among others, could cause actual
results to differ materially from those described in the forward-looking statements : the
ability of Sanofi-Synthélabo to expand its presence profitably in the United
States; the success of Sanofi-Synthélabo’s research and development programs;
the ability of Sanofi-Synthélabo to protect its intellectual property rights; and
the risks associated with reimbursement of health care costs and pricing reforms,
particularly in the United States and France.
Investors and security holders may
obtain a free copy of documents filed by Sanofi-Synthélabo with the french
« Commission des Opérations de bourse » (COB) at
www.cob.fr and with the U.S. Securities and Exchange Commission at www.sec.gov or
directly from Sanofi-Synthélabo on the web site www. sanofi-synthelabo. com
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