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News
Europe's drug committee has backed a new, more convenient dosing schedule for cemiplimab (Libtayo) across all six of its EU-approved cancer indications. After 12 weeks of standard dosing, patients could switch to a higher dose every six weeks — cutting infusion frequency in half. A final European Commission decision is expected within months.
Europe's top drug advisory body, the CHMP, has issued a positive opinion recommending a new dosing regimen for cemiplimab (Libtayo) that would apply across all six of its currently approved cancer indications in the EU. The updated schedule allows patients to start with 350 mg every three weeks for the first 12 weeks, then transition to 700 mg every six weeks — effectively halving how often they need to come in for treatment. A shorter 15–30 minute infusion option is also on the table for eligible patients, potentially cutting chair time significantly.
The recommendation is backed by pharmacokinetic modeling, simulations, and clinical data — most notably from the phase 3 C-POST trial in high-risk cutaneous squamous cell carcinoma (CSCC). That trial showed a striking benefit for cemiplimab over placebo, with disease-free survival events occurring in just 13.9% of cemiplimab patients vs. 33.0% on placebo. A final decision from the European Commission is expected in the coming months.
By the Numbers
Why it matters: Reducing infusion frequency is a meaningful quality-of-life win for cancer patients and could ease the burden on infusion centers. If the European Commission greenlights the change, patients across six cancer types — including NSCLC, CSCC, basal cell carcinoma, and cervical cancer — stand to benefit from a more flexible treatment schedule.
