Orphan designation: Sorafenib tosilate Treatment of papillary thyroid cancer, 13/11/2013 Expired
The effects of sorafenib tosylate have been evaluated in experimental models.
At the time of submission of the application for orphan designation, clinical trials with sorafenib tosylate in patients with papillary thyroid cancer were ongoing.
At the time of submission, sorafenib tosylate was authorised in the EU for the treatment of hepatocellular carcinoma (a type of liver cancer) and advanced renal-cell carcinoma (a type of kidney cancer).
At the time of submission, sorafenib tosylate was not authorised anywhere in the EU for papillary thyroid cancer. Orphan designation of sorafenib tosylate had been granted in the United States, Australia and Switzerland for some types of thyroid cancer, including papillary thyroid cancer.
In accordance with Regulation (EC) No 141/2000 of 16 December 1999, the COMP adopted a positive opinion on 9 October 2013 recommending the granting of this designation.
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