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Cemiplimab - Regeneron Pharmaceuticals

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Drug Profile

Cemiplimab - Regeneron Pharmaceuticals

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

Latest Information Update: 23 Aug 2024

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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

Highest Development Phases

  • Marketed Basal cell cancer; Non-small cell lung cancer; Squamous cell cancer
  • Registered Cervical 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

Most Recent Events

  • 19 Aug 2024 Phase-III clinical trials in Malignant melanoma (Inoperable/Unresectable, Metastatic disease, Late-stage disease, First-line therapy, Combination therapy) in USA (IV) (NCT06246916)
  • 07 Jun 2024 Phase-II clinical trials in Non-small cell lung cancer (Newly diagnosed, Early-stage disease, Combination therapy) in USA (IV) (EudraCT2023-505172-29-00) (NCT06161441)
  • 31 May 2024 Efficacy and adverse events data from a phase-II trial in cervical cancer presented at the 60th Annual Meeting of the American Society of Clinical Oncology (ASCO-2024)

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