FDA Approves Taxotere(R) for the Treatment of Patients With Advanced Stomach Cancer
Posted on: Friday, 24 March 2006, 18:00 CST
NEW YORK, March 24 /PRNewswire/ -- THIS IS A MULTIVU REPORT.
THE AMERICAN CANCER SOCIETY ESTIMATES OVER 22 THOUSAND NEW CASES OF STOMACH CANCER WILL BE DIAGNOSED IN THE U-S THIS YEAR, AND ONLY 11.5% OF THOSE PATIENTS WILL BE ALIVE AT TWO YEARS. 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.
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.
DR. JAFFER A. AJANI, MD ANDERSON CANCER CENTER:
"The FDA approval of Taxotere(R) fulfils an unmet need in patients with advanced stomach cancer who have had very limited options."
THE ADDITION OF TAXOTERE(R) TO THE STANDARD TREATMENT RESULTED IN MORE SIDE EFFECTS; HOWEVER, THIS REGIMEN ALONG WITH APPROPRIATE RISK MANAGEMENT SHOWS PROMISE IN THE TREATMENT OF ADVANCED STOMACH CANCER.
I'M DANIELLE ADDAIR. 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 o You have any allergies
o 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
o You have symptoms of an allergic reaction (warm sensation, tightness in your chest, itching/hives, or shortness of breath)
o 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.
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CONTACT: FOR STORY INFORMATION, PLEASE CALL: MultiVu Media Relations,1-800-653-5313, EXT. 3 OR EMAIL RADIO@MULTIVU.COM
Web site: http://www.taxotere.com/
Source: PRNewswire
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