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FDA approves Exelixis’ Cometriq for rare thyroid cancer

Genomics-based discovery company also submits the drug to EU regulators

Exelixis has received approval from the US Food and Drug Administration (FDA) for the use of Cometriq to treat a rare thyroid cancer.

The drug can now be prescribed for use in patients with metastatic medullary thyroid cancer –  a type of thyroid cancer that develops in thyroid gland cells that make a hormone called calcitonin, which helps to regulate calcium levels in the blood.

The approval follows a similar recommendation for AstraZeneca's Caprelsa (vandetanib) last year, with both drugs now available for use in this limited population.

According to the National Cancer Institute, 56,460 Americans will be diagnosed with thyroid cancer, while 4 per cent of thyroid cancers are medullary thyroid cancer.

“Cometriq is the second drug approved to treat medullary thyroid cancer in the past two years and reflects FDA's commitment to the development and approval of drugs for treating rare diseases,” said Dr Richard Pazdur, director of the office of haematology and oncology products in the FDA's Center for Drug Evaluation and Research.

“Prior to today's approval and the approval of Caprelsa in April 2011, patients with this rare and difficult to treat disease had limited therapeutic treatment options.”

Cometriq was approved under the FDA's priority review programme, due to the unmet medical need in medullary thyroid cancer, and was also granted orphan designation.

In clinical trials, it has been shown to extend the length of time a patient can live without the cancer progressing by an average of 7 months compared to placebo.

Exelixis also announced it has submitted Cometriq for marketin authorisation in the EU.

This application to the European Medicines Agency contains the same data from the clinical trials, during which the drug showed it can extend progression free survival.

Cometriq is also a designated orphan in the EU due to the limited number of patients it will be available to treat.

3rd December 2012

From: Sales



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