Overview
- On 16 October, the EMA’s CHMP issued a positive opinion recommending Libtayo monotherapy for adjuvant treatment of adults with CSCC at high risk of recurrence after surgery and radiation.
- A final decision by the European Commission is expected in the coming months, with an updated Summary of Product Characteristics to follow and the drug remaining under additional monitoring.
- In the phase 3 C-POST trial, adjuvant cemiplimab reduced the risk of recurrence or death by 68% versus placebo (HR 0.32), with median disease-free survival not reached versus 49.4 months and 24‑month DFS of 87.1% versus 64.1%.
- Safety findings in C-POST were consistent with prior studies of cemiplimab, with immune‑related adverse events largely manageable using standard treatment algorithms.
- The FDA approved the same adjuvant indication in the United States on 8 October 2025, extending Libtayo’s use beyond advanced or unresectable disease.