EMA's Scientific Committee Backs Expanded Use Of Exelixis, Ipsen's Cabometyx In Thyroid Cancer

Exelixis Inc EXEL and its partner Ipsen SA IPSEY have received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for Cabometyx (cabozantinib) for thyroid carcinoma.

• The opinion covers Cabometyx as a monotherapy for locally advanced or metastatic differentiated thyroid carcinoma (DTC), refractory or not eligible to radioactive iodine (RAI) who have progressed during or after prior systemic therapy. 
• The European Commission will now review the CHMP recommendation, and a final decision on the application is expected in the coming months.
• The CHMP recommendation is based on results from COSMIC-311 Phase 3 trial that demonstrated significant improvement in progression-free survival (PFS) with Cabometyx versus placebo. 
• Also See: Bristol Myers, Exelixis Tout Additional Opdivo/Cabometyx Combo Data From Kidney Cancer Trial.
• The FDA has approved Cabometyx for locally advanced or metastatic DTC.
• Cabometyx is currently approved in the European Union for advanced renal cell carcinoma (RCC).
• Price Action: EXEL shares are down 0.12% at $21.51 during the market session on the last check Friday.