西米普利单抗 cemiplimab

Drug Class

PD-1 blocking monoclonal antibody

Mechanism

Binds to the PD-1 receptor on T-cells, blocking its interaction with PD-L1 and PD-L2, thereby restoring T-cell mediated anti-tumor immune responses.

Approved Indication

Treatment of adult patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or radiation.

What This Means For Patients

Libtayo (cemiplimab) is a PD-1 blocking monoclonal immunotherapy approved by the FDA and EMA for advanced cutaneous squamous cell carcinoma and other malignancies. It works by unleashing the body's immune system to recognize and attack cancer cells. Under special import pathways, eligible patients can access this treatment in the Boao Lecheng pilot zone.

Regulatory Approvals

• FDA — approved (2018) — label
• EMA — approved (2019) — source

Pivotal Clinical Evidence

• Study 1540 — Migden et al., N Engl J Med 2018 (NCT02760498) — DOI

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761097s000lbl.pdf
• https://www.ema.europa.eu/en/medicines/human/EPAR/libtayo