基于CHMP去年12月给出的积极推荐意见，欧盟委员会3月25日有条件批准了 生物技术公司Exelixis的Cometriq(cabozantinib)用于治疗疾病进展的、不可手术切除的成人晚期甲状腺髓样癌。Cometriq该适应症曾获得欧盟的孤儿药资格，FDA已于2012年11月29日批准Cometriq。
Exelixis Receives Approval for COMETRIQ(R) (Cabozantinib) in the European unio for Treatment of Progressive, Unresectable Locally Advanced or me-tastatic Medullary Thyroid Carcinoma
Exelixis, Inc. (NASDAQ:EXEL) today announced that the European Commission has approved COMETRIQ(R) (cabozantinib) for the treatment of adult patients with progressive, unresectable locally advanced or me-tastatic medullary thyroid carcinoma (MTC). The European 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, 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 are pleased that physicians who treat patients with progressive, unresectable locally advanced or me-tastatic MTC in the European unio will now have COMETRIQ as a treatment option," said Michael Morrissey, Ph.D., president and chief executive officer of Exelixis. "This patient population is in need of new therapies, and we believe that COMETRIQ provides an imp0rtant new option for these patients."
Additionally, the Committee for Orphan Medicinal Products (COMP) during its January 2014 meeting reviewed the designation for COMETRIQ (cabozantinib) as an orphan medicinal product for the treatment of medullary thyroid carcinoma and recommended maintenance of orphan drug designation at the time of marketing authorization.
The U.S. Food and Drug Administration approved COMETRIQ for the treatment of progressive, me-tastatic MTC in the United States on November 29, 2012. The approvals of COMETRIQ in both the United States and the European unio were based on data from EXAM, the international, multi-center, randomized double-blinded controlled phase 3 clinical trial conducted in 330 patients with progressive, unresectable locally advanced or me-tastatic MTC, in which cabozantinib met its primary efficacy endpoint of improving progression-free survival (PFS) as compared to placebo. Please see imp0rtant Safety Information for COMETRIQ, including Boxed Warnings, below.
Pursuant to the terms of a commercialization and distribution agreement between Exelixis and Swedish Orphan Biovitrum (Sobi) signed in February 2013, Sobi will support the commercialization of COMETRIQ in the European unio for the approved indication through the end of 2015.
ab0ut Cabozantinib
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, me-tastasis, tumor angiogenesis, and maintenance of the tumor microenvironment.
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