Ipsen: CHMP Recommends Approval Of Cabometyx - Quick Facts

(RTTNews) - Ipsen announced the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended approval of Cabometyx 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. The CHMP positive opinion was based on results from the COSMIC-311 phase III trial.

The company noted that the positive CHMP opinion follows the FDA's approval in September 2021 of Cabometyx for the treatment of adult and pediatric patients 12 years of age and older with locally advanced or metastatic DTC that has progressed following prior vascular endothelial growth factor receptor targeted therapy and who are radioactive iodine-refractory or ineligible.