sanofi-aventis announced that following a priority review of a supplemental New Drug Application (sNDA), the US Food and Drug Administration (FDA) has 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).
This approval follows a positive opinion for the same use granted on September 29, 2006 by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA), a sanofi-aventis press release said.
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-based (docetaxel, cisplatin and fluorouracil) regimen 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-based regimen 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 per cent 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, cisplatin, 5-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 in inoperable locally advanced squamous cell carcinoma of the head and neck (SCCHN), this approval marks the tenth indication for Taxotere® (the seventh in the United States), which is already approved for use in the treatment of some of the most common cancers.
Taxotere is currently approved in 4 different indications.
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 doxorubicine 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 US 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 US 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 androgenindependent (hormone-refractory) metastatic prostate cancer in the US 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 2005, 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.