IPSEY - Ipsen Exelixis' Cabometyx gets approval in EU to treat thyroid cancer subtype

European Commission (EC) approved Ipsen (OTCPK:IPSEF) (OTCPK:IPSEF) and Exelixis' (EXEL) Cabometyx as a standalone therapy for certain patients with differentiated thyroid cancer (DTC). The EC approval allows for the use of of Cabometyx (cabozantinib) to treat adult patients with locally advanced or metastatic DTC, refractory or not eligible to radioactive iodine who have progressed during or after prior systemic therapy. The companies said the approval marks the first treatment option to be specifically approved as a second-line therapy in this indication in Europe. The EC decision follows a recommendation of approval by the EMA's Committee for Medicinal Products for Human Use in March. The approval was backed by data from a phase 3 trial called COSMIC-311, which showed that the drug caused a reduction in the risk of disease progression or death by 78% versus placebo. In the EU, Cabometyx is already approved to treat certain patients with kidney and liver cancer. Cabometyx

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Ipsen, Exelixis' Cabometyx gets approval in EU to treat thyroid cancer subtype