The European Commission ( EC ) 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.
The Committee for Orphan Medicinal Products ( COMP ) also reviewed the designation for Cometriq as an orphan medicinal product for the treatment of medullary thyroid carcinoma, and recommended maintenance of orphan drug designation at the time of marketing authorisation.
The Food and Drug Administration ( FDA ) approved Cometriq for the treatment of progressive, metastatic medullary thyroid carcinoma 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 medullary thyroid carcinoma, in which Cabozantinib met its primary efficacy endpoint of improving progression-free survival ( PFS ) as compared to placebo.
Cabozantinib inhibits the activity of tyrosine kinases including RET, MET and VEGFRs. These receptor tyrosine kinases are involved in both normal cellular function and in pathologic processes such as oncogenesis, metastasis, tumor angiogenesis, and maintenance of the tumor microenvironment. ( Xagena )
Source: Swedish Orphan Biovitrum AB ( SOBI ), 2014