The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending an extended dosing regimen for cemiplimab (Libtayo) across all of the drug's approved cancer indications in the European Union (EU), Regeneron Pharmaceuticals announced October 16, 2026.¹ The recommendation would let patients move to a 700 mg intravenous infusion every 6 weeks after an initial 12-week induction period of 350 mg every 3 weeks, the same regimen already approved in the EU solely for adjuvant treatment of high-risk cutaneous squamous cell carcinoma (CSCC).¹
Key facts
- Drug: Cemiplimab (Libtayo); Regeneron Pharmaceuticals
- Class: PD-1 inhibitor, fully human monoclonal antibody
- Status: Positive CHMP opinion issued; EC decision pending
- Proposed regimen: 700 mg IV every 6 weeks after 12-week induction (350 mg every 3 weeks)
- Scope: All 6 EU-approved indications, if adopted
- Already approved for: Adjuvant high-risk CSCC (EU, November 2025)
- Infusion option: 350 mg dose infusion time reducible to 15-30 minutes
- Current EU indications: CSCC, BCC, NSCLC, cervical cancer
The CHMP also recommended a separate option to shorten the infusion time for the 350 mg dose from 30 minutes to as little as 15 minutes for patients whose first infusion was well tolerated, which Regeneron said could cut treatment time by up to half.¹ The European Commission (EC) is expected to issue a final decision within the next few months.¹
The positive opinion is supported by pharmacokinetic and pharmacodynamic modeling and simulation data, integrated with clinical safety and efficacy data from Libtayo's existing clinical development program, according to Regeneron.¹ If the EC adopts the recommendation, the extended 6-week maintenance regimen would become available across all 6 of Libtayo's approved EU indications, rather than remaining limited to the adjuvant CSCC setting where it currently applies.¹
How does the extended regimen compare with cemiplimab's current dosing?
Cemiplimab is currently dosed at 350 mg by intravenous infusion every 3 weeks across most of its EU-approved indications, which include advanced basal cell carcinoma, non-small cell lung cancer, and cervical cancer, in addition to CSCC.¹ The only exception is adjuvant treatment of high-risk CSCC after surgery and radiation, where the 350 mg/700 mg induction-then-maintenance schedule under review today was approved by the EC in November 2025, following an earlier CHMP opinion recommending the adjuvant indication itself.¹,² That regimen matches the dosing used in the phase 3 C-POST trial, in which adjuvant cemiplimab reduced the risk of disease recurrence or death by 68% compared with placebo (hazard ratio, 0.32; 95% confidence interval, 0.20-0.51) among 415 patients.³
