Following promising results in a phase III trial, the drug Taxotere has been given the green light for use in people with head and neck cancer.
Taxotere is produced by drug company Sanofi-aventis and already has approval in the U.S. for the treatment of breast, prostate, lung and gastric cancers; this new approval makes it the fifth tumor type for which Taxotere can be used.
The Food and Drug Administration (FDA) in the United States says Taxotere can now be used in combination with cisplatin and 5-fluorouracil before the start of chemotherapy and prior to surgery.
According to drug maker Sanofi-aventis the approval for Taxotere as an induction therapy was based on a phase III randomized, open-label, international trial, which established the efficacy of the drug.
Each year 640,000 people are diagnosed with head and neck cancer and some 350,000 die from the disease which includes cancers of the oral cavity, salivary glands, paranasal sinuses and nasal cavity, pharynx and larynx.
The trial found that when Taxotere was given in conjunction with cisplatin and 5-fluorouracil, the risk of death in cancer patients was reduced by 30 percent compared to patients receiving just cisplatin and 5-fluorouracil.
The survival in the Taxotere group was 70.6 months compared to 30.1 months in the other group.