- The European Commission (EC) has approved Ipsen SA's (OTC: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 (NASDAQ: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.
