BRIDGEWATER, N.J., Oct. 18 /PRNewswire-FirstCall/ -- Sanofi-aventis announced today that following a priority review of a 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 fluorouracil for the induction treatment of patients with inoperable locally advanced squamous cell carcinoma of the head and neck (SCCHN). This approval follows a positive opinion for the same use granted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) in September of this year.
The FDA based its decision on results from the EORTC 24971/TAX 323 phase III, open-label, randomized study, which enrolled 358 patients with SCCHN.
Patients receiving the Taxotere(R)-based regimen also had a significantly longer progression-free survival of 11.4 months, compared with 8.3 months (p=0.0077) for the patients receiving a standard therapy. Patients treated with the Taxotere(R)-based regimen (Taxotere(R), cisplatin and fluorouracil) prior to radiation (with or without a surgical component) had a significantly longer median overall survival compared to a standard treatment of cisplatin and fluorouracil (18.6 vs 14.2 months), with a 29 percent risk reduction of death (p=0.0055), a benefit of more than four months improvement in median survival. In the study, induction chemotherapy (also called neoadjuvant therapy) was the first step in treating the disease prior to radiation therapy or surgical intervention.
"Survival rates for advanced head and neck cancer have historically been low," said Marshall Posner, MD, medical director of the head and neck oncology program at Dana-Farber Cancer Institute in Boston. "This study has shown that induction therapy with a Taxotere(R), cisplatin, fluorouracil (TPF) regimen increases survival. With this approval, I hope to see TPF become the standard of care for induction therapy for patients with this type of cancer."
After the recent positive opinion given by the European authorities for the recommendation of Taxotere(R) in inoperable locally advanced squamous cell carcinoma of the head and neck (SCCHN) this approval marks the tenth indication for Taxotere(R) (the seventh in the United States), which is already approved for use in the treatment of some of the most common cancers.
About the EORTC 24971/TAX 323 Study
In the trial, patients were randomly assigned to receive one of two treatments. Of the 358 participants, 177 received an infusion of Taxotere(R) 75 mg/m2 plus cisplatin 75 mg/m2 on day one, and a five-day continuous infusion of fluorouracil 750 mg/m2/d; 181 patients received an infusion of a standard treatment consisting of cisplatin 100 mg/m2 on day one followed by a five-day continuous infusion of fluorouracil 1000 mg/m2/d. Treatment cycles were repeated every three weeks for a total of four cycles. Patients received radiation therapy following chemotherapy within four to seven weeks after completing the last cycle of chemotherapy. Radiation therapy was administered five days a week for up to seven weeks. Surgery before radiation therapy (neck dissection) or three months after radiation therapy (residual disease) was permitted.
Patients in the Taxotere(R) arm (TPF) compared to the cisplatin and fluorouracil arm (PF) had grade 3 and 4 neutropenia 76.3% to 52.8%, alopecia 10.9% to 0%, anemia 9.2% to 13.8% and infection 8.6% to 7.7%. Patients receiving the PF regimen showed greater grade 3-4 nausea (7.2 percent vs. 0.6 percent), vomiting (5.0 percent vs. 0.6 percent) and stomatitis (11.0 percent vs. 4.0 percent). Commonly seen adverse events in the Taxotere(R) base regimen included febrile neutropenia (5.2%) and neutropenic infection (13.9%).
About Head and Neck Cancer
More than 640,000 people worldwide are diagnosed with head and neck cancer each year, and more than 350,000 die from the disease annually. Head and neck cancer is a group of many related diseases that mostly begin in the cells that line the mucosal surfaces in the head and neck area such as the mouth, nose and throat. The term encompasses cancers of the oral cavity, salivary glands, paranasal sinuses and nasal cavity, pharynx, larynx, and lymph nodes in the upper part of the neck.
Indications and Usage
Taxotere(R) is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy.
Taxotere(R) in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-positive breast cancer.
Non-Small Cell Lung Cancer (NSCLC)
Taxotere(R), as a single agent, is indicated for the treatment of patients with locally advanced or metastatic NSCLC after failure of prior platinum- based chemotherapy.
Taxotere(R) in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic NSCLC who have not previously received chemotherapy for this condition.
Taxotere(R) in combination with prednisone is indicated for the treatment of patients with androgen independent (hormone refractory) metastatic prostate cancer.
Taxotere(R) in combination with cisplatin and flourouracil is indicated for the treatment of patients with advanced gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for advanced disease.
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.
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 full prescribing information, including boxed WARNING,call 800-633- 1610 or visit www.fda.gov/cder/foi/label/2006/020449s039lbl.pdf.
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)
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Contact: Marisol Peron, sanofi-aventis, (908) 243-7592, email@example.com
CONTACT: Marisol Peron of sanofi-aventis, +1-908-243-7592, or