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Aventis Receives Priority Review Designation for the
Registrational Application to Support the Use of Taxotere(R) in Women with
Early-Stage Breast Cancer
New indication would expand the role of Taxotere(R) in the treatment of the
disease
BRIDGEWATER, N.J., May 18 /PRNewswire-FirstCall/ -- Aventis announced today
that the U.S. Food and Drug Administration (FDA) has granted a Priority Review
designation for the registrational application to support the use of
Taxotere(R) (docetaxel) Injection Concentrate for the treatment of women with
early-stage operable breast cancer with involved axillary lymph nodes. Aventis
submitted a supplemental New Drug Application (sNDA) for the additional
indication on March 18, 2004. The Priority Review designation means that the
FDA will target an agency action on or before September 17, 2004.
The supplemental application is based on data from a large, well- controlled
phase III study that found the combination of Taxotere, doxorubicin and
cyclophosphamide (TAC) to significantly improve overall survival in women with
early-stage breast cancer and reduce their risk of a relapse compared with the
standard regimen of 5-fluorouracil, doxorubicin and cyclophosphamide (FAC).
A Priority Review designation is assigned by the FDA for those applications
that have the potential for providing a significant therapeutic advance.
"The FDA's Priority Review designation of Taxotere recognizes its potential as
an important treatment option to help extend the lives of women with node
positive early-stage breast cancer," said Frank Douglas, MD, PhD, Executive
Vice President of Drug Innovation and Approval and a Member of the Board of
Management at Aventis.
These data, from the Breast Cancer International Research Group (BCIRG) 001/
TAX 316 study, were presented at the San Antonio Breast Cancer Symposium on
December 5, 2003 and demonstrated that women with node-positive, early- stage
breast cancer who received TAC after surgery experienced a 30 percent reduction
in the risk of death at a 55-month follow-up and a 28 percent reduction in the
chance of their cancer returning as compared to women treated with FAC.
Benefit for TAC over FAC was observed regardless of nodal, hormone- receptor or
HER-2/neu status.
Breast Cancer
Breast cancer is the most common cancer among women other than skin cancer. It
is the second-leading cause of cancer death in women after lung cancer -- and
is the leading cause of cancer death among women ages 40 to 59. More than
1,000,000 new cases of breast cancer are reported worldwide annually and more
than 300,000 women die each year from the disease. The risk of a woman
developing breast cancer during her lifetime is approximately 11 percent (about
one in nine of all women), with about three to four percent dying of the
disease.
About Taxotere
Taxotere, a drug in the taxoid class of chemotherapeutic agents, inhibits
cancer cell division by essentially "freezing" the cell's internal skeleton,
which is comprised of microtubules. Microtubules assemble and disassemble
during a cell cycle. Taxotere promotes their assembly and blocks their
disassembly, thereby preventing many cancer cells from dividing and resulting
in cancer cell death.
Taxotere is currently approved in the United States to treat patients with
locally advanced or metastatic breast cancer after failure of prior
chemotherapy, and patients with unresectable locally advanced or metastatic
non-small cell lung cancer (NSCLC) in combination with cisplatin, who had not
received prior chemotherapy. It also is approved for patients with
unresectable locally advanced or metastatic NSCLC after failure of prior
platinum-based chemotherapy.
Among patients receiving Taxotere the most common severe adverse events were
low blood cell count, fatigue, diarrhea, and mouth and throat irritation.
The most common non-severe side effects include hair loss, numbness, a tingling
and/or burning sensation, rash, nail changes, nausea, vomiting, and muscle
pain.
Less common severe or potentially life threatening side effects include fluid
retention, infections, and allergic reactions.
Patients 65 years of age or older may experience some side effects more
frequently. For more information about Taxotere, visit
http://www.taxotere.com/ or see full prescribing information including boxed
WARNINGS. For more information about ongoing clinical trials, please call
1-800-RxTrial or visit http://www.aventisoncology.com/.
About Aventis
Aventis is dedicated to treating and preventing disease by discovering and
developing innovative prescription drugs and human vaccines. In 2003, Aventis
generated sales of euro 16.79 billion (US $18.99), invested euro 2.86 billion
(US $3.24) in research and development and employed approximately 69,000 people
in its core business. Aventis corporate headquarters are in Strasbourg, France.
The company's prescription drugs business is conducted in the U.S. by Aventis
Pharmaceuticals Inc., which is headquartered in Bridgewater, New Jersey. For
more information, please visit: http://www.aventis-us.com/.
Statements in this news release containing projections or estimates of
revenues, income, earnings per share, capital expenditures, capital structure,
or other financial items; plans and objectives relating to future operations,
products, or services; future economic performance; or assumptions underlying
or relating to any such statements, are forward-looking statements subject to
risks and uncertainties. Actual results could differ materially depending on
factors such as the timing and effects of regulatory actions, the results of
clinical trials, the company's relative success developing and gaining market
acceptance for new products, the outcome of significant litigation, and the
effectiveness of patent protection. Additional information regarding risks and
uncertainties is set forth in the current Annual Report on Form 20-F of Aventis
on file with the Securities and Exchange Commission and in the current Annual
Report -"Document de Reference"- on file with the "Autorite des marches
financiers" in France.
Pursuant to Article 7 of the COB Regulation no. 2002-04, this press release was
transmitted to the Autorite des marches financiers before its release
DATASOURCE: Aventis Pharmaceuticals
CONTACT: Lisa Kennedy, US Product Communications, +1-908-243-6361,
, or Marisol Peron, US Product Communications,
+1-908-243-7592, , both of Aventis
Web site: http://www.aventis-us.com/
http://www.aventisoncology.com/
http://www.taxotere.com/