Aventis (NYSE:AVE)
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Aventis Receives FDA Approval for Taxotere(R) in Prostate Cancer
BRIDGEWATER, N.J., May 19 /PRNewswire-FirstCall/ -- Aventis announced today
that the U.S. Food and Drug Administration (FDA) has approved Taxotere(R)
(docetaxel) Injection Concentrate for use in combination with prednisone as a
treatment for men with androgen-independent (hormone-refractory) metastatic
prostate cancer.
The FDA approval is based on the final results of a landmark phase III clinical
trial that met its primary endpoint of increasing survival in this patient
population. The pivotal study, TAX 327, along with an additional study of
Taxotere in this patient population, have been selected for presentation at the
Plenary Session at the American Society of Clinical Oncology (ASCO) annual
meeting on Monday, June 7, in New Orleans, LA. A regulatory submission for
Taxotere in prostate cancer is also pending with the European Agency for the
Evaluation of Medicinal Products (EMEA).
"This approval for Taxotere provides evidence that our drug can positively
impact the lives of men around the world with this disease. In addition, this
latest FDA action makes Taxotere the only drug approved for breast, lung and
prostate cancer, three of the most prevalent cancers in the world today," said
Frank Douglas, MD, PhD, Executive Vice President of Drug Innovation and
Approval and a Member of the Board of Management at Aventis.
About Prostate Cancer
Prostate cancer ranks third worldwide in cancer incidence and sixth in cancer
mortality among men. In the United States, more than 230,000 American men will
be diagnosed with prostate cancer this year, and more than 29,900 will die of
the disease.
Current therapy for advanced prostate cancer is hormonal manipulation (i.e.,
blockage of androgen hormones like testosterone that would otherwise stimulate
the growth of prostate cancer cells). However, the effects of this treatment
typically last between 24 and 36 months, at which time patients may become
refractory to hormonal therapy and be considered candidates for chemotherapy,
such as Taxotere.
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 "Commission des
Operations de Bourse" in France, recently renamed "Autorite des marches
financiers".
DATASOURCE: Aventis
CONTACT: Lisa Kennedy, +1-908-243-6361, or Marisol Peron,
+1-908-243-7592, , both of U.S. Product
Communications, Aventis
Web site: http://www.aventis-us.com/
http://www.taxotere.com/
http://www.aventisoncology.com/