EU approves Cabometyx in thyroid carcinoma.
Exelixis announced that its partner Ipsen received approval from the European Commission (EC) for Cabometyx (cabozantinib) as a monotherapy for the treatment of adult patients with locally advanced or metastatic differentiated thyroid carcinoma (DTC), refractory or not eligible to radioactive iodine (RAI) who have progressed during or after prior systemic therapy.
The EC approval is based on results from COSMIC-311, the phase III pivotal trial that demonstrated significant improvement in progression-free survival (PFS) with Cabometyx versus placebo in patients with RAI-refractory DTC who progressed after up to two prior VEGFR-targeted therapies. COSMIC-311 was the basis for the FDA approval of Cabometyx in September 2021 for the treatment of adult and pediatric patients 12 years of age and older with locally advanced or metastatic DTC that has progressed following VEGFR-targeted therapy and who are RAI-refractory or ineligible.
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