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MultiVu Video Feed: FDA Approves New Treatment For Patients With Advanced Stomach Cancer

Posted on: Thursday, 23 March 2006, 18:00 CST

NEW YORK, March 23 /PRNewswire/ -- 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 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 TAXOTERE(R)- 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.

SATELLITE FEEDS: Thursday, March 23rd, Friday, March 24th, Friday, March 24th, 2006 2006 2006 6:30 PM - 6:45 PM ET 3:00 AM - 3:15 AM ET 2:00 PM - 2:15 PM ET IA 6 IA 6 IA 6 Transponder 15 Transponder 15 Transponder 16 C-Band C-Band C-Band Downlink Freq: Downlink Freq: Downlink Freq: 4000 Vertical 4000 Vertical 4020 Horizontal Preview and access this video on Pathfire DMG: 24003 Search within the PR Newswire or MultiVu section by story ID # 24003 or by headline For technical assistance call Pathfire Customer Care at 1-888-345-0489 or e-mail support@pathfire.com FORMAT: News Package With Extra Soundbites and B-roll.

ADDITIONAL RESOURCES: Video, contact information and more available at http://www.prnewswire.com/broadcast/24003/consumer.shtml

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 About TAXOTERE(R) Important safety information

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

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

Taxotere(R) 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(R) 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(R) 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(R). Women of childbearing potential should avoid becoming pregnant during treatment with Taxotere(R).

Before receiving Taxotere(R), 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(R), 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 TAXOTERE(R), visit http://www.taxotere.com/. For full prescribing information, including boxed WARNING, call 800-633-1610.

Video: http://www.prnewswire.com/broadcast/24003/press.shtml

sanofi-aventis

CONTACT: For technical information or hard copy, please call:MultiVu Media Relations, 800-653-5313 EXT. 3

Web site: http://www.multivu.com/http://www.taxotere.com/

Source: PRNewswire

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