Sanofi-Aventis has announced this morning that US regulators have approved another application of its big-selling cancer drug Taxotere.
The US Food and Drug Administration has approved Taxotere (docetaxel) in combination with cisplatin and 5-fluorouracil, for induction therapy of locally advanced squamous cell carcinoma of the head and neck (SCCHN) before patients undergo chemoradiotherapy and surgery. This latest green light for the treatment is based on the results of the Phase III randomised, open-label, international trial called TAX 324, which showed that overall survival in patients treated with Taxotere-based therapy was significantly improved compared to those receiving just cisplatin and 5-fluorouracil.
Clinical investigator Marshall Posner, medical director of the head and neck oncology program at Dana-Farber Cancer Institute in Boston, USA, said that the approval of Taxotere to be given in combination with other standard chemotherapy, “as the first step in a therapeutic sequence followed by chemoradiotherapy and surgery,” is a significant advancement in treatment for patients with locally advanced head and neck cancer. The drug is already approved for the induction therapy of inoperable advanced SCCHN and this latest go-ahead is the eighth FDA approval for Taxotere in five different tumour types.
The new Taxotere approval comes a couple of days after the FDA approved a higher-dosage, 300mg tablet form of bloodthinner blockbuster Plavix (clopidogrel). The new tablet will make it easier for patients to take the agency-approved loading dose for appropriate acute coronary syndrome patients as soon as possible after hospital admission. Plavix is now typically taken in 75mg doses.