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Zactima Receives Fast Track Designation By The FDA

by Medindia Content Team on February 6, 2006 at 3:41 PM
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Zactima Receives Fast Track Designation By The FDA

ZACTIMA a product of AstraZeneca has been granted fast track designation by the US Food and Drug Administration (FDA). The drug also received the orphan drug designation recently for treatment of anaplastic, medullary, follicular, locally advanced and metastatic medullary thyroid cancer. Following the approval, investigation of the drug in the treatment of medullary thyroid carcinoma is expected to accelerate further.

Medullary thyroid cancer accounts for 5 to 10% of all thyroid cancers. Surgery, nuclear medicine (treatment with radioactive iodine), hormonal manipulation, external beam radiotherapy (direction of radiation to kill cancer cells from outside the body) and chemotherapy represent some of the available treatment options.

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Presently, there is no satisfactory chemotherapy regimen or other treatment modality for the cure of advanced thyroid cancer. Only those drugs, used for the treatment of severe diseases for which there is an unfulfilled medical need would be granted fast-track status by the FDA.

The fast track review by the FDA would be of immense help in the development of the drug and regulation of the submission process. The pharmaceutical company is currently involved in Phase II clinical trials of the drug, directed against metastatic or locally advanced medullary thyroid cancer.
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The compound is believed to play a major role in the inhibition of the growth and spread of the thyroid cancer by participating in vital cell signalling pathways. Vascular endothelial growth factor receptor (VEGFR) and epidermal growth factor receptor (EFGR) participate in the inhibition pathway while REarranged during Transfection (RET) tyrosine kinases can accelerate the growth of the same.

If the treatment is found to be successful, then we might soon have a new treatment modality for the treatment of medullary thyroid cancer.

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