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March 25, 2014
07:09 EDTEXELExelixis announces Cometriq approved in Europe
Exelixis announced that the European Commission has approved Cometriq for the treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma, or MTC. The European Commission granted conditional marketing authorisation following a positive opinion from the European Committee for Medicinal Products for Human Use, or CHMP, issued in December 2013. Similar to another drug approved in this setting, the approved indication states that for patients in whom Rearranged during Transfection mutation status is not known or is negative, a possible lower benefit should be taken into account before individual treatment decisions. The Committee for Orphan Medicinal Products also reviewed the designation for Cometriq as an orphan medicinal product for the treatment of MTC, and recommended maintenance of orphan drug designation at the time of marketing authorisation.
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