The CHMP has issued a positive opinion recommending approval of an alternative dosing schedule for Libtayo (cemiplimab) across all approved indications.
The opinion supports reducing dosing frequency from every three weeks to every six weeks after the first 12 weeks of treatment. It also recommends an optional reduction of infusion time for the 350 mg dose to 15 to 30 minutes, provided the first dose over 30 minutes was well tolerated.
A spokesperson for Regeneron said: “The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the approval of an alternative dosing schedule for Libtayo across all approved indications.”
They added: “The positive CHMP opinion is supported by comprehensive pharmacokinetic and pharmacodynamic modeling and simulation data, integrated with clinical safety and efficacy data from Libtayo’s clinical development program.”
The recommendation supports a higher-dose 700 mg infusion every six weeks following an initial 12-week regimen of 350 mg every three weeks.
It also allows a shorter infusion option for patients continuing on the 350 mg schedule. The European Commission is expected to make a final decision in the coming months, which would enable the updated regimen to be applied across all six approved indications.
The 700 mg six-week option is already approved in the US for use after 12 weeks as an adjuvant treatment for adults with cutaneous squamous cell carcinoma at high risk of recurrence. Across other indications, the existing 350 mg three-week regimen remains in place.
Libtayo is a fully human monoclonal antibody targeting PD-1 and has been approved in more than 30 countries for certain adult patients with advanced BCC, CSCC, NSCLC and cervical cancer.
It is also being investigated in trials as a monotherapy and in combination approaches for other solid tumours, although these potential uses remain investigational and unapproved.
