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Biotech / Medical : Exelixis, Inc. (EXEL)
EXEL 46.52-0.2%Dec 24 12:59 PM EST
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From: Ian@SI3/25/2014 6:42:42 PM
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and this was good for a 17 cent gain today...

Exelixis receives approval for COMETRIQ in the European Union for treatment of progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma ( EXEL) 6.27 :
  • Co announced that the European Commission has approved COMETRIQ for the treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma.
  • The European Commission granted conditional marketing authorization following a positive opinion from the European Committee for Medicinal Products for Human Use (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. Pursuant to the terms of a commercialization and distribution agreement between Exelixis and Swedish Orphan Biovitrum (Sobi) signed in February 2013, Sobi will support the commercialization of COMETRIQ in the European Union for the approved indication through the end of 2015.
  • The FDA approved COMETRIQ for the treatment of progressive, metastatic MTC in the United States on November 29, 2012. The approvals of COMETRIQ in both the United States and the European Union were based on data from EXAM, the international, multi-center, randomized double-blinded controlled phase 3 clinical trial conducted in 330 patients with progressive, unresectable locally advanced or metastatic MTC, in which cabozantinib met its primary efficacy endpoint of improving progression-free survival (PFS) as compared to placebo.
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