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Home Industry News AstraZeneca fast tracked by FDA

AstraZeneca fast tracked by FDA

6th February 2006

The US Food and Drug Administration (FDA) has granted AstraZeneca thyroid cancer treatment Zactima (ZD6474) fast track status.

The fast track designation for the treatment for medullary thyroid carcinoma allows the firm to seek FDA input into development plans and gives the option of a rolling submission of the New Drug Application (NDA).

There is currently no curative modality or approved chemotherapy for advanced thyroid cancer.

Dr Peter Langmuir, AstraZeneca senior director of medical science, said: “We are pleased to receive fast track designation for Zactima for the treatment of medullary thyroid cancer, and are committed to evaluating the potential of Zactima as a new treatment option for patients with this disease.”

Zactima is now in Phase II trials for medullary thyroid cancer treatment and was given orphan-drug designation last year for the treatment of patients with follicular, medullary, anaplastic, and locally advanced and metastatic papillary thyroid cancer.

It works by blocking signals that lead to tumour growth and blood supply to the tumour.

track© Adfero Ltd

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