Libtayo® (cemiplimab) Recommended for EU Approval by the CHMP for Updated Dosing Regimen Across All Approved Cancer Types
Regeneron announced that the EMA's CHMP adopted a positive opinion recommending approval of an alternative Libtayo dosing schedule across all approved indications in the EU. The recommended regimen shifts to 700 mg every six weeks after an initial 12 weeks of 350 mg every three weeks, and adds an optional 15-30 minute infusion for the 350 mg dose, cutting treatment time by up to half.
Key figures
- Drug Name
- Libtayo (cemiplimab)
- New regimen
- 700 mg IV every six weeks after initial 12 weeks of 350 mg every three weeks
- Infusion option
- 15-30 minute infusion for 350 mg dose after well-tolerated first 30-minute infusion
- Approved indications in eu
- 6
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