Research & Development
European Commission Approves Cabometyx as a Second-Line Treatment for People Living with Radioactive Iodine-Refractory Differentiated Thyroid Cancer
4 May 2022 - - The European Commission has approved the use of Cabometyx (cabozantinib) as a monotherapy for the treatment of adult patients with locally advanced or metastatic differentiated thyroid carcinoma, refractory or not eligible to radioactive iodine who have progressed during or after prior systemic therapy, France-based Ipsen (Euronext: IPN) (OTC: IPSEY) said.

This approval is the first of its kind in Europe for this uncommon condition, with limited treatment options currently available should patients progress after prior use of systemic therapy.

The EC approval was based on results from the pivotal COSMIC-311 Phase III trial, which at a planned interim analysis, confirmed that the trial had met the primary endpoint of progression free survival, demonstrating a significant reduction in the risk of disease progression or death by 78% versus placebo (hazard ratio [HR]: 0.22; 96% confidence interval [CI]: 0.13-0.36; P
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