Sanofi-Aventis says that its blockbuster oncology drug Taxotere has given priority review status from US regulators as it bids for an approval in another indication, this time for head and neck cancer.
The Franco-German drugmaker noted that the US Food and Drug Administration has accepted for filing and assigned priority review status to the supplemental new drug application for Taxotere (docetaxel) in combination with cisplatin and fluorouracil for the induction therapy of patients with locally-advanced squamous cell carcinoma of the head and neck prior to chemoradiotherapy and surgery.
Taxotere, in combination with cisplatin and fluorouracil, is approved for the induction therapy of inoperable advanced SCCHN and if it gets the go-ahead, it will be the eighth FDA approval for the drug in five different tumour types. The review of Sanofi’s sNDA is expected to be completed by the autumn.
“We are very pleased that FDA has granted priority review to Taxotere as part of a sequential treatment program that also includes chemoradiotherapy and surgery for advanced head and neck cancer,” said Nassir Habboubi, vice president of US medical affairs, oncology. “We are hopeful that Taxotere may soon be available for many patients suffering from advanced head and neck cancer.”
The FDA submission is based on results of TAX 324, a randomised, open-label, international Phase III trial presented at the American Society of Clinical Oncology meeting in 2006 showing a Taxotere-based regimen, versus standard chemotherapy, improved overall survival as part of a sequential treatment plan for locally advanced SCCHN. All patients entering
the study had stage III or IV cancer with no distant metastases and had tumours of the oral cavity, oropharynx, larynx or hypopharynx that could not be removed or were considered operable but unlikely to be cured with surgery, or tumors that could not be removed in order to preserve crucial organs.
Positive data on Apidra
The news on Taxotere came after Sanofi presented results from a new study at the American Diabetes Association meeting in Chicago which showed that adding the firm’s Apidra (insulin glulisine) to a basal insulin and oral antidiabetic drug therapy (BOT) will provide an effective treatment option for people with type 2 diabetes unable to control their blood sugar, despite good titration with BOT alone.
The findings are from the first prospective study assessing the benefits of adding a single dose of rapid-acting Apidra to BOT for the treatment of people with type 2 diabetes who were inadequately controlled.
When a single dose of Apidra was added to a regimen with Sanofi’s own Lantus (insulin glargine) serving as the basal insulin, A1C was significantly reduced at endpoint. Overall, 84.2% of participants reached the post-prandial target and taking Apidra at the main meal showed a similar response rate in lowering A1C compared with taking the drug at breakfast.