Libtayo® (cemiplimab) Recommended for EU Approval by the CHMP for Updated Dosing Regimen Across All Approved Cancer Types

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of an alternative dosing schedule for Libtayo (cemiplimab) across all approved cancer indications. The new regimen allows for extended dosing of 700 mg every six weeks after an initial 12-week treatment with 350 mg every three weeks, and optional reduction of infusion time to 15-30 minutes. The European Commission is expected to make a final decision in the coming months.