Libtayo® (cemiplimab) Recommended for EU Approval by the CHMP for Updated Dosing Regimen Across All Approved Cancer Types
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The Libtayo 700 mg every six-week option is already approved in the EU after an initial 12 weeks as adjuvant treatment for adult CSCC patients at high risk of recurrence after surgery and radiation.
60% confidenceThe European Commission is expected to make a final decision in the coming months, which would allow the dosing regimen to be applied across all six approved indications in the EU.
60% confidenceOncology assets in clinical development comprise nearly half of Regeneron's pipeline, and Libtayo serves as the backbone of many investigational combinations.
60% confidenceThe CHMP adopted a positive opinion recommending approval of an alternative dosing schedule for Libtayo across all approved indications.
60% confidenceThe 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.
60% confidence