Healthcare Industry News:  stomach cancer 

Biopharmaceuticals Oncology FDA

 News Release - March 23, 2006

TAXOTERE(R) Receives U.S. FDA Approval For Use In Advanced Stomach Cancer

TAXOTERE(R)-based regimen demonstrates a 23% reduction in the risk of mortality in patients with advanced stomach cancer

BRIDGEWATER, N.J., March 23 (HSMN NewsFeed) -- 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 TAXOTEREŽ (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 TAXOTEREŽ- based chemotherapy regimen (TAXOTEREŽ plus cisplatin and 5-fluorouracil, TCF) experienced a significant 23 percent 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 TAXOTEREŽ-containing regimen (9.2 vs 8.6 months, p=<0.02) with a hazard ratio of 1.29 (95% CI: 1.04-1.61). Time to disease progression was nearly two months longer in the TAXOTEREŽ- containing arm (5.6 vs 3.7 months, p=0.0004), 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 TAXOTEREŽ-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 percent. This study was undertaken to evaluate the benefits of adding TAXOTEREŽ to a standard chemotherapy regimen. The primary study endpoint was time to tumour progression (TTP), which was significantly improved with TAXOTEREŽ based therapy (5.6 months) compared to standard treatment (3.7 months) with a 32 percent reduction in the risk of progression (log-rank test p=0.0004). 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 percent of the patients experienced at least one Grade 3-4 (severe) side effect with the TAXOTEREŽ- based regimen versus 75.4 percent in the control arm, with neutropenia being the most common Grade 3-4 side effect in the TAXOTEREŽ- based regimen. The most common side effects (all grade) associated with the TAXOTEREŽ- 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 TAXOTEREŽ arm, febrile neutropenia and/or neutropenic infection occurred in 12 percent of patients receiving secondary prophylactic G-CSF compared to 28 percent who did not, which represents a 57 percent reduction.

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

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

In Breast Cancer:

* In the United States TAXOTEREŽ is approved for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy,

* TAXOTEREŽ 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):

* TAXOTEREŽ, 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,

* TAXOTEREŽ 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:

* TAXOTEREŽ 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, "The approval of TaxotereŽ 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 4th 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 percent.


Important safety information

WARNING: TaxotereŽ 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).

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

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

TaxotereŽ 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 TaxotereŽ 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 TaxotereŽ 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 TaxotereŽ. Women of childbearing potential should avoid becoming pregnant during treatment with TaxotereŽ.

Before receiving TaxotereŽ, 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 TaxotereŽ, 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

For more information about TAXOTEREŽ, visit For full prescribing information, including boxed WARNING, call 800-633-1610.

About sanofi-aventis

sanofi-aventis is the world's 3rd largest pharmaceutical company, ranking number 1 in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic disorders, central nervous system, internal medicine, and vaccines. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY )

Source: sanofi-aventis

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