Libtayo® (cemiplimab) Recommended for EU Approval by the CHMP for Updated Dosing Regimen Across All Approved Cancer Types
Globe Newswire•16/10/2026•07:00 ET
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Key Highlights
- ➤CHMP recommends Libtayo 700 mg every six weeks after initial 12-week regimen
- ➤Regeneron (REGN) could apply alternative dosing across all six EU indications
- ➤350 mg infusion time may fall to 15–30 minutes after first-dose tolerability
- ➤European Commission expected to decide on application in coming months
Positive opinion supports reducing Libtayo dosing frequency from every three weeks to every six weeks after first 12 weeks of treatment
Optional reduction of infusion time for 350 mg dose to 15 to 30 minutes, after a well-tolerated first dose over 30 minutes, also recommended by CHMP
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