EU approval for Cometriq in medullary thyroid carcinoma
The European Commission has approved Cometriq (cabozantinib), a drug for the treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma (MTC), from Swedish Orphan Biovitrum (STO: SOBI) and partner Exelixis (Nasdaq: EXEL).
The 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 (AstraZeneca’s Caprelsa; vandetanib), 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.
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