Ipsen - Exelixis' Cabometyx Scores European Approval As Second-Line Treatment For Thyroid Cancer - Ipsen (OTC:IPSEF), Exelixis (NASDAQ:EXEL), Ipsen (OTC:IPSEY)

The European Commission (EC) has approved Ipsen SA's IPSEY Cabometyx (cabozantinib) as monotherapy in differentiated thyroid carcinoma (DTC) setting.
The approval covers adult patients with locally advanced or metastatic DTC, refractory or not eligible for radioactive iodine, who have progressed during or after systemic therapy.
This EC approval follows the FDA approval announced by Exelixis Inc EXEL in September 2021 of Cabometyx for adult and pediatric patients with locally advanced or metastatic DTC.
The approval was based on results from the COSMIC-311 Phase 3 trial, which at a planned interim analysis, demonstrated a significant reduction in the risk of disease progression or death by 78% versus placebo.
The objective response rate also favored Cabometyx with 15% vs. 0% for placebo (p=0.028) but did not meet the criteria for statistical significance.
At a median follow-up of 10.1 months, the final results demonstrated Cabometyx's median PFS of 11.0 months versus 1.9 months with placebo and a maintained reduction in disease progression or death risk of 78% versus placebo.
Price Action: EXEL shares closed 1.43% higher at $22.66 on Monday.