CHMP recommends Cometriq for Thyroid Cancer-Exelixis Inc.
Exelixis, Inc. has announced that the European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion of the Marketing Authorization Application (MAA) for Cometriq (cabozantinib) for the treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary Thyroid Carcinoma (MTC). The proposed indication also 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 MAA contains data from EXAM, the international, multi-center, randomized double-blinded controlled phase III 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.
Swedish Orphan Biovitrium will market the drug in the EU.
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