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Taxotere (Docetaxel) Receives U.S. FDA Approval For Use In Advanced Stomach Cancer

Taxotere-based regimen demonstrates a 23% reduction in the risk of mortality in patients with advanced stomach cancer

BRIDGEWATER, N.J. -- March 23, 2006 -- Sanofi-aventis announced today that following a priority review of the supplemental new drug application (sNDA), the U.S. Food and Drug Administration (FDA) has approved Taxotere(R) (docetaxel) Injection Concentrate in combination with cisplatin and 5-fluorouracil for the treatment of patients with advanced stomach (gastric) cancer, including cancer of the gastro esophageal (GE) junction, who have not received prior chemotherapy for advanced disease.

This is the first FDA approval of an advanced stomach cancer treatment demonstrating a survival advantage in more than a decade, thereby offering physicians and their patients an important new option for treating this devastating disease. The additional new application is also currently under review by the Committee for Medicinal products for Human Use (CHMP) of the European Agency for the Evaluation of Medicinal Products (EMEA).

The FDA based its decision on results from the TAX 325 study, the largest international phase III clinical trial in previously untreated advanced stomach cancer, involving 445 patients. Patients treated with the Taxotere-based chemotherapy regimen (Taxotere plus cisplatin and 5-fluorouracil, TCF) experienced a significant 23% reduction in the risk of death compared to patients who received a current standard treatment of cisplatin and 5-fluorouracil (CF), (median follow-up: 23 months).

The median overall survival was significantly longer with the Taxotere-containing regimen (9.2 vs. 8.6 months, P =<.02) with a hazard ratio of 1.29 (95% CI: 1.04-1.61). Time to disease progression was nearly two months longer in the Taxotere- containing arm (5.6 vs. 3.7 months, P =.0004), hazard ratio 1.47 (CF/TCF 95% CI/ 1.19 -1.83).

"For many years, patients with gastric cancer had limited options for the treatment of their disease," said Jaffer A. Ajani, MD, Professor, GI Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas, Principal Investigator of the TAX 325 study "With the approval of this Taxotere-based regimen in this cancer, a new standard of treatment is now available for advanced gastric cancer patients."

About the TAX 325 Study
Locally advanced or metastatic stomach cancer has a poor prognosis with a low long-term survival of only 11.5%. This study was undertaken to evaluate the benefits of adding Taxotere to a standard chemotherapy regimen. The primary study endpoint was time to tumour progression (TTP), which was significantly improved with Taxotere based therapy (5.6 months) compared to standard treatment (3.7 months) with a 32% reduction in the risk of progression (log-rank test P =.0004).

The main secondary endpoint was to detect a statistically significant increase in overall survival. Other secondary objectives included response rate, time to treatment failure, duration of response, safety profiles, quality of life and disease related symptoms.

In total, 81.4% of the patients experienced at least one Grade 3-4 (severe) side effect with the Taxotere- based regimen versus 75.4% in the control arm, with neutropenia being the most common Grade 3-4 side effect in the Taxotere-based regimen. The most common side effects (all grade) associated with the Taxotere-based regimen were anemia, neutropenia, diarrhea, and nausea.

The most common side effects (all grade) associated with the cisplatin and 5-fluorouracil arm were anemia, neutropenia, nausea and vomiting. Primary prophylactic use of growth factor support (granulocyte-colony stimulating factor, G-CSF) was not allowed per the study protocol. G-CSF is a bone marrow growth factor that may be administered to reduce febrile neutropenia in patients receiving myelosuppressive chemotherapy. In the Taxotere arm, febrile neutropenia and/or neutropenic infection occurred in 12% of patients receiving secondary prophylactic G-CSF compared to 28% who did not, which represents a 57% reduction.

These results were last presented at the American Society of Clinical Oncology (ASCO) annual meeting in 2005.

With this new indication, Taxotere is now approved for six indications in the United States in four different tumor types:

In Breast Cancer:
* In the United States Taxotere is approved for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy,
* Taxotere is approved in combination with doxorubicin and cyclophosphamide (TAC regimen) for the adjuvant treatment of patients with operable, node-positive breast cancer.

In Non-Small Cell Lung Cancer (NSCLC):
* Taxotere, in combination with cisplatin, is approved for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not received prior chemotherapy for this condition,
* Taxotere is also approved, as a single agent, for the treatment of patients with locally advanced or metastatic NSCLC after failure of prior platinum-based chemotherapy.

In Prostate cancer:
* Taxotere is approved for use in combination with prednisone for the treatment of patients with androgen-independent (hormone-refractory) metastatic prostate cancer.

"Stomach cancer claims the lives of more than 700,000 people worldwide each year," said Donna Vining, President, Gastro Esophageal Cancer Foundation, http://www.gecancer.org. "The approval of Taxotere for use in advanced stomach cancer contributes to the on-going efforts by the medical community to find treatment options that may improve outcomes for those suffering from this devastating disease."

About Stomach Cancer
Stomach cancer is the 4^th most common type of cancer worldwide with more than 934,000 new patients every year. It is also the second most common cause of cancer death worldwide; with more than 700,000 deaths annually. There were about 22,800 new cases of stomach cancer in the United States in 2005. In Europe, this number is over 143,000 patients. At diagnosis, most patients with stomach cancer have advanced disease with an expected two-year survival of only 11.5%.

About Taxotere
Important safety information
WARNING: Taxotere treatment can cause serious, physically limiting, and potentially life-threatening side effects, such as infection, low blood- cell counts, allergic reaction, and retention of excess fluid (edema).

Taxotere should not be given to patients with low white-blood-cell counts, abnormal liver function, or a history of allergic reactions to Taxotere or any of the ingredients in Taxotere.

Before each Taxotere treatment, all patients treated with Taxotere must receive another medicine called dexamethasone. This drug can help reduce the risk of fluid retention (edema) and allergic reactions.

Taxotere should be administered only under the supervision of a qualified physician experienced in the use of anticancer treatments. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available.

Treatment-related acute myeloid leukemia (AML) has occurred in patients given anthracyclines and/or cyclophosphamide, including use with Taxotere in adjuvant therapy for breast cancer.

The most common severe side effects are low white-blood-cell count, anemia, fatigue, diarrhea, and mouth and throat irritation. Low white-blood- cell count can lead to life-threatening infections. The earliest sign of infection may be fever, so tell your doctor right away if you have a fever.

Other common side effects from Taxotere include nausea, vomiting, hair loss, rash, infusion-site reactions, odd sensations (such as numbness, tingling, or burning) or weakness in the hands and feet, nail changes, muscle and/or bone pain, or excessive tearing.

Patients 65 years of age or older may experience some side effects more frequently than younger patients.

Because of the potential risk of fetal harm, pregnant women should not receive Taxotere. Women of childbearing potential should avoid becoming pregnant during treatment with Taxotere.

Before receiving Taxotere, tell your doctor if:
* You have any allergies
* You are taking any other medicines - including nonprescription (over-the-counter) drugs, vitamins, and dietary or herbal supplements

When taking Taxotere, contact your doctor if:
* You have symptoms of an allergic reaction (warm sensation, tightness in your chest, itching/hives, or shortness of breath)
* You experience any other side effects


SOURCE: Sanofi-aventis

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