Drug Profile

Cemiplimab - Regeneron Pharmaceuticals

Alternative Names: Cemiplimab-rwlc; Libtayo; REGN-2810; SAR-439684

Latest Information Update: 09 Feb 2026

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At a glance

Originator Regeneron Pharmaceuticals
Developer BioNTech; Columbia University; Dana-Farber Cancer Institute; Inovio Pharmaceuticals; ISA Pharmaceuticals; Regeneron Pharmaceuticals; Replimune; Sanofi; SillaJen Biotherapeutics; Sun Pharmaceutical Industries; University of Texas M. D. Anderson Cancer Center; University of Zurich
Class Antineoplastics; Immunotherapies; Monoclonal antibodies
Mechanism of Action Antibody-dependent cell cytotoxicity; Programmed cell death 1 receptor antagonists; T lymphocyte stimulants

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

Yes - Cervical cancer
New Molecular Entity Yes

Marketed Basal cell cancer; Cervical cancer; Non-small cell lung cancer; Squamous cell cancer
Phase III Malignant melanoma
Phase II Glioblastoma; Haemangiosarcoma; Head and neck cancer; Liver cancer; Oropharyngeal cancer; Prostate cancer
Phase I/II Fallopian tube cancer; Multiple myeloma; Ovarian cancer; Peritoneal cancer; Solid tumours
No development reported B-cell lymphoma; Cancer; Haematological malignancies; Renal cell carcinoma

31 Dec 2025 Preregistration for Squamous cell cancer (Adjuvant therapy) in Japan (IV)
31 Dec 2025 Regeneron Pharmaceuticals files regulatory application for adjuvant treatment of patients with Squamous cell carcinoma in Japan
15 Dec 2025 Regeneron pharmaceutical plans a phase II trial for Colorectal cancer (Late-stage disease, Monotherapy, Combination therapy, Neoadjuvant therapy, First-line therapy) in USA (IV) (NCT07281768)

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