Quick navigation menu :
  1. Go to content
  2. Go to the main sections menu
  3. Go to the subsections menu
  4. Go to the search engine
  5. Go to the languages menu
  6. Go to the help menu
  7. Go to contact slot
You are here:
  1. Home
  2. > Press room
  3. > Press releases
  4. > Year 2007
Languages menu :
 

Contacts

Press Relations
Tel. :
(33) 1 53 77 4450
Fax :
(33) 1 53 77 4622
Adress :
174, avenue de France
75013 PARIS
FRANCE
Switchboard :
(33) 1 53 77 4000
Content :

Press releases

WarningPress releases and press packs are intended to journalists, investors and shareholders. 

Paris, France  October 22, 2007

Taxotere® receives positive opinion from the Committee for Medicinal Products for Human Use (CHMP) recommending approval in the European Union for induction treatment for locally advanced Head and Neck cancer

Sanofi-aventis announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has granted a positive opinion for the use of Taxotere® (docetaxel) in combination with cisplatin and 5 -fluorouracil for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN). The CHMP based its decision on the significant improvement of survival demonstrated by the results of the phase III trial, Tax 324, (71 months with the Taxotere® -based regimen versus 30 months with the control regimen).
The US Food and Drug Administration (FDA) approved Taxotere® for this additional indication on September 28, 2007.
For many years, we have waited for a new therapeutic option for this very difficult pathology”, said Marshall Posner, MD, Medical Director of the Head and Neck Oncology Program at Dana-Farber Cancer Institute in Boston. “The survival improvement seen with this Taxotere®-based regimen is extraordinary for locally advanced squamous cell carcinoma, and will provide a new, multidisciplinary approach to the management of our patients.

Taxotere® is currently approved in 5 different cancer types in Europe and the US and this new indication for Taxotere® is the 11th in Europe (the 8th in the US).

Approval Based on Clinical Trial Tax 324

Patients were treated with for three cycles of chemotherapy every three weeks with either TPF (Taxotere 75mg/m² plus cisplatin 100mg/m² and 5-fluorouracil 1000mg/m² a day for four days) or PF (intravenous cisplatin 100mg/m² followed by 5-fluorouracil 1000mg/m² a day for five days), the standard therapy. Both groups of patients were then given weekly chemotherapy (carboplatin) together with radiation therapy for seven weeks, followed by surgery for those patients identified as candidates. The study was designed primarily to evaluate overall survival. Secondary endpoint included progression-free survival, response rates, toxicity, quality of life and clinical benefits.

Patients entering Tax 324 had tumors of the oropharynx, larynx, hypopharynx or oral cavity that either could not be removed, were considered potentially operable but unlikely to be cured with surgery, or could not be removed in order to preserve larynx function. Participants in the trial had either stage III or IV SCCHN with no distant metastases.

Among patients treated with Taxotere®-based therapy (TPF, n=255) overall survival was significantly improved compared to patients receiving just cisplatin and 5-fluorouracil (PF, n=246); the relative risk of death was 30% lower (HR 0.70; p=0.0058). Patients treated with TPF had a longer median overall survival of 71 months vs. 30 months for patients receiving PF, representing a more than three year improvement in median OS for patients treated with TPF. Survival at three years was 62% in the TPF arm compared to 48% in the PF arm.

Overall, the incidence of grade 3/4 toxicity was 65% in the Taxotere® arm (TPF) compared to 62% in the group receiving cisplatin and fluorouracil (PF). Patients treated with TPF had more febrile neutropenia (12% vs 7%), neutropenic infection (12% vs 8%), and grade 3/4 neutropenia (84% vs. 56%), alopecia (4% vs 1%) and diarrhea (7% vs. 3%) than those in the PF group. Patients in the PF group had more grade 3/4 thrombocytopenia (11% vs. 4%), stomatitis (27% vs. 21%), lethargy (10% vs. 5%) and vomiting (10% vs. 8%). The incidence of other grade 3/4 events was similar between the two groups, such as nausea, anorexia and constipation. The incidence of treatment delays was significantly lower in the TPF group indicating a diminution of the toxicity in this treatment arm. Patients treated in the TPF arm received a prophylactic antibiotherapy in order to better control the hematological toxicity, mainly febrile neutropenia.

Head and Neck Cancer, a Deadly Disease

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, tongue, tonsils, throat and voicebox. 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.

About Taxotere®

Taxotere® is currently approved in 5 different cancer types in Europe and the US:

In Breast Cancer

In the United States and in Europe Taxotere® is approved to treat patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy. It is also approved in Europe in combination with doxorubicin for patients who have received prior cytotoxic therapy for this condition and in combination with capecitabine after failure of cytotoxic therapy which would have included anthracycline. In the adjuvant setting (post surgery) it is approved in the U.S. and in Europe in combination with doxorubicin and cyclophosphamide (TAC regimen) for the treatment of patients with operable, node-positive breast cancer. Finally, in Europe, Taxotere® is approved in combination with trastuzumab for the treatment of patients with metastatic breast cancer- overexpressing HER2 receptor.

In Lung Cancer

In the U.S. and in Europe, Taxotere®, 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, and it also is approved, as a single agent, for patients with unresectable locally advanced or metastatic NSCLC after failure of prior platinum-based chemotherapy.

In Prostate Cancer

Taxotere® is approved for use in combination with prednisone as a treatment for androgen independent (hormone-refractory) metastatic prostate cancer in the U.S. and in Europe.

In Gastric (Stomach) Cancer

The FDA and the Committee for Medicinal Products for Human Use (CHMP) of the European Agency for the Evaluation of Medicinal Products (EMEA) approved in March 2006, the use of Taxotere® Injection Concentrate in combination with cisplatin and 5-fluorouracil for the treatment of patients with advanced stomach (gastric) cancer, including cancer of the gastro oesophageal (GE) junction, who have not received prior chemotherapy for advanced disease.

In Head and Neck Cancer

In October 2006, the European Medicines Agency (EMEA) and the FDA approved Taxotere® (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). In September 2007, the FDA approved Taxotere® in combination with cisplatin and 5-fluorouracil for the induction therapy of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN) prior to chemoradiotherapy and surgery.

About sanofi-aventis

Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

Forward Looking Statement

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include financial projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future events, operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although sanofi-aventis’ management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in sanofi-aventis’ annual report on Form 20-F for the year ended December 31, 2006. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.

© sanofi-aventis 2004-2008 | Legal notice | Update: February 4, 2008