CHMP backs Exelixis' Cometriq

EMA's CHMP issued a positive opinion recommending approval of an MAA for Cometriq cabozantinib from Exelixis Inc. (NASDAQ:EXEL) to treat progressive, unresectable locally advanced or metastatic medullary thyroid cancer (MTC). Swedish Orphan Biovitrum AB (SSE:SOBI) has rights to distribute and commercialize the product for MTC in in the EU, Switzerland, Norway, Russia, Turkey and certain other European countries. The spectrum-selective kinase inhibitor of VEGF receptor 2 ( KDR/Flk-1; VEGFR-2) and c-Met receptor tyrosine kinase has Orphan Drug status for the indication.

In January, Exelixis launched Cometriq in the U.S. to treat progressive, metastatic MTC. The company reported $10.7 million in net revenues for the drug through Sept. 30. ...