CHMP backs extended Libtayo dosing schedule across approved EU cancer indications

Regeneron has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use supporting a new dosing schedule for Libtayo, also known as cemiplimab, across all of its approved cancer indications in the European Union.

The recommendation would allow patients to move from treatment every three weeks to a higher-dose regimen administered once every six weeks after the first 12 weeks of therapy.

Under the proposed schedule, patients would initially receive Libtayo 350 mg as a 30-minute intravenous infusion every three weeks.

After 12 weeks, treatment could switch to Libtayo 700 mg administered over 30 minutes every six weeks.

The CHMP also recommended an optional shorter infusion time for patients continuing on the 350 mg every three-week regimen.

Patients who tolerate their first 350 mg infusion over 30 minutes could subsequently receive the same dose over 15 to 30 minutes.

Regeneron said this could reduce infusion time by as much as half for some patients.

The positive opinion is supported by pharmacokinetic and pharmacodynamic modelling and simulation, together with clinical efficacy and safety data generated across the Libtayo development programme.

If approved by the European Commission, the updated schedule would apply across all six indications for which Libtayo is currently approved in the European Union.

The 700 mg every six-week regimen is already approved in the EU following an initial 12 weeks of treatment for adults receiving Libtayo as adjuvant therapy for cutaneous squamous cell carcinoma at high risk of recurrence after surgery and radiation.

For Libtayo’s other approved indications, patients currently receive the 350 mg dose every three weeks as a 30-minute intravenous infusion.

The proposed change would therefore expand the less frequent schedule across the medicine’s wider European oncology indications.

The European Commission is expected to make a final decision on the application in the coming months.

If approved, the extended dosing schedule could reduce the frequency of hospital or clinic visits required for treatment while maintaining exposure supported by the pharmacokinetic and clinical evidence.

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