Exelixis Inc (NASDAQ:EXEL) and its partner Ipsen SA (OTC: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.
