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.

"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, vice president Sobi Partner Products, which has rights to market the product for the approved indication in Europe under an agreement with Exelixis (The Pharma Letter February 22, 2013).