- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of Exelixis (EXEL +0.9%) and licensee Ipsen's (OTCPK:IPSEY) Cabometyx (cabozantinib) for the treatment of advanced renal cell carcinoma in adult patients who have been previously treated with a vascular endothelial growth factor (VEGF)-targeted therapy.
- Cabozantinib inhibits enzymes called tyrosine kinases, which play roles in the proliferation and survival of cancer cells.
- Exelixis owns commercialization rights in the U.S. and Canada while Ipsen has the rights elsewhere except Japan. The FDA approved it in April.
- Carbozantinib is also marketed in the U.S. under the brand name Cometriq for the treatment of medullary thyroid cancer, an indication approved by the FDA in November 2012.
- A final decision from the European Commission usually takes ~60 days.
- Previously: Exelixis inks cabozantinib commercialization deal with Ipsen valued as high as $855M; shares up 9% after hours (Feb. 29)