FDA APPROVES NEW TREATMENT FOR PATIENTS WITH ADVANCED STOMACH CANCER

Story Summary:

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 FDA based its decision on results from the Tax 325 study, the largest international phase III trial in previously untreated advanced stomach cancer involving 445 patients.

Stomach cancer claims the lives of more than 700,000 people each year. According to the American Cancer Society, over 22,000 new patients will be diagnosed with stomach cancer in the United States this year, and more than 11,000 people will die of the disease in 2006.

The most common side effects associated with the TAXOTEREŽ- based regimen were anemia, neutropenia, diarrhea, and nausea. The most common side effects associated with the cisplatin and 5-fluorouracil arm were anemia, neutropenia, nausea and vomiting.

Soundbites

• DR. JAFFER A. AJANI, GI Medical Oncologist, MD, Anderson Cancer Center and Principal Investigator in the Tax 325 Clinical Study

B-Roll Includes

• Mechanism of Action animation footage
• Exterior shots of FDA
• Exterior shots of MD Anderson Cancer Center / Dr. Ajani
• Product/packaging shots

VIDEO PROVIDED BY: "sanofi-aventis"