Sanofi-Aventis receives positive CHMP opinion for Taxotere

Sanofi-Aventis as has announced that Taxotere (doxetaxel) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency as a treatment for locally advanced squamous cell carcinoma of the head and neck (SCCHN) in conjunction with cisplatin and 5-flouracil.

This decision has been based on the phase III Tax 324 trial which showed significant improvement of survival, measured at 71 months for the Taxotere-based treatment regimen and 30 months with the control therapy.

Last month, the compound was approved by the US Food and Drug Administration for this indication.

Taxotere is currently approved for breast, lung, gastric, prostate and head and neck cancer.

Marshall Posner, medical director of the head and neck oncology programme at Dana-Farber
Cancer Institute in Boston, said: “For many years, we have waited for a new therapeutic option for this very difficult pathology.”

He added that the improvements seen with treatment regimens based on Taxotere offers a novel multidisciplinary approach to managing patients with this condition.

Earlier this month, Sanofi-Aventis reported that the addition of Taxotere to standard induction chemotherapy can add years to patients’ lives.