Exelixis, Inc. (NASDAQ:EXEL) today 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 CHMP's positive opinion will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union.
The MAA upon which the CHMP issued its opinion contains 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 metastatic MTC, in which cabozantinib met its primary efficacy endpoint of improving progression-free survival (PFS) as compared to placebo. This trial also served as the basis for Exelixis’ New Drug Application with the U.S. Food and Drug Administration, which approved COMETRIQ for the treatment of progressive, metastatic MTC in the United States on November 29, 2012. Please see Important Safety Information for COMETRIQ, including Boxed WARNINGS, below.
“The positive opinion issued by the CHMP marks an important milestone for Exelixis and the next step in making COMETRIQ commercially available in the European Union,” said Michael Morrissey, Ph.D., president and chief executive officer of Exelixis. “We are looking forward to working with the European Commission to complete the review process for COMETRIQ’s proposed indication as a treatment for progressive, unresectable locally advanced or metastatic MTC.”
If the European Commission approves COMETRIQ based on the CHMP’s positive opinion, Swedish Orphan Biovitrum (Sobi) would support the product’s commercialization in the European Union for the approved indication through the end of 2015, pursuant to the terms of a commercialization and distribution agreement between Exelixis and Sobi signed in January 2013.