Europagodkännande för Cometriq®

Swedish Orphan Biovitrum today announced that the European Commission has approved Cometriq® (cabozantinib) for the treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma (MTC). The European Commission granted conditional marketing authorisation 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 (RET) mutation status is not known or is negative, a possible lower benefit should be taken into account before individual treatment decisions.

”We’re pleased that physicians in the European Union who treat patients with progressive, unresectable locally advanced or metastatic MTC now have a new treatment option in Cometriq,” said Anders Edvell, MD, PhD, Vice President Sobi Partner Products.

The Committee for Orphan Medicinal Products (COMP) also reviewed the designation for Cometriq (cabozantinib) as an orphan medicinal product for the treatment of MTC, and recommended maintenance of orphan drug designation at the time of marketing authorisation.

The U.S. Food and Drug Administration 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-centre, randomised 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.

Pursuant to the terms of a commercialization and distribution agreement between Exelixis and Sobi signed in February 2013, Sobi will support the commercialisation of Cometriq in the European Union for the approved indication through the end of 2015.