The Committee for Medicinal Products for Human Use of the European Medicines Agency recommended approval 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.
When conducting a randomized clinical trial of a treatment regimen based on an immune checkpoint inhibitor, trial sponsors should include overall survival as an endpoint, FDA officials say.
