FDA Approves Cemiplimab for Patients With Cutaneous Squamous Cell Carcinoma in the Adjuvant Setting
On October 8, 2025, the US Food and Drug Administration approved cemiplimab for the adjuvant treatment of patients with cutaneous squamous cell carcinoma (cSCC) who are at high risk for recurrence following surgery and radiation. This approval was based on data from the C-POST trial.
This double-blind, randomized, phase 3 trial enrolled 415 patients with cSCC at high risk for recurrence following surgery and radiation. All patients completed adjuvant radiation therapy within 2 to 10 weeks of randomization. Patients were randomized on a 1-to-1 basis to receive either cemiplimab (n = 209) or placebo (n = 206). The major efficacy outcome measure was disease-free survival (DFS), defined as the time from randomization to the first documented disease recurrence by investigator assessment, or death due to any cause.
With a median follow-up duration of 24 months, the median DFS was not reached in the cemiplimab arm and was 49.4 months in the placebo arm (hazard ratio, 0.32; P < .0001). The prescribing information for cemiplimab includes warnings and precautions for immune-mediated adverse reactions, infusion-related reactions, complications of allogenic hematopoietic stem cell transplantation (HSCT), and embryo-fetal toxicity.
The recommended dose of cemiplimab is 350 mg intravenously every 3 weeks for 12 weeks, followed by 700 mg every 6 weeks or 350 mg every 3 weeks until disease recurrence, unacceptable toxicity, or up to 48 weeks.
Source:
FDA approves cemiplimab-rwlc for adjuvant treatment of cutaneous squamous cell carcinoma. Published online: October 8, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cemiplimab-rwlc-adjuvant-treatment-cutaneous-squamous-cell-carcinoma
