Regeneron shared on X:
“We are pleased to share that the European Medicines Agency’s CHMP has recommended approval of an alternative dosing regimen for our immunotherapy across its currently approved skin, lung, and cervical cancer indications.
Release Details
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending an updated dosing regimen for Libtayo (cemiplimab) across all its approved cancer indications in the European Union.
The recommended schedule would allow patients to receive a 700 mg dose through a 30-minute intravenous infusion every six weeks, following an initial 12 weeks of treatment with 350 mg every three weeks. The CHMP also recommended an option to shorten the infusion time for the 350 mg dose to 15–30 minutes, provided the first infusion was well tolerated over 30 minutes.
According to Regeneron, the recommendations are supported by pharmacokinetic and pharmacodynamic modeling and simulation, alongside clinical safety and efficacy data. The European Commission is expected to make a final decision on the application in the coming months.
Read the full announcement: Regeneron’s Official Press Release.”
You can also read: Regeneron’s Cemiplimab Receives CHMP Backing for Six-Weekly Dosing Across EU Indications
