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Cemiplimab

Generic Name
Cemiplimab
Brand Names
Libtayo
Drug Type
Biotech
CAS Number
1801342-60-8
Unique Ingredient Identifier
6QVL057INT

Overview

Cemiplimab is a fully human monoclonal antibody that works against programmed death receptor-1 (PD-1), which is a negative regulator of T cell function. By blocking PD-1, cemiplimab works to enhance T cell-mediated antitumour responses. Cemiplimab was first approved by the FDA on September 28, 2018, as the first FDA-approved treatment for advanced cutaneous squamous cell carcinoma (CSCC). It was later approved to be used in basal cell carcinoma and non-small non-small cell lung cancer. Cemiplimab was also approved by the European Commission on June 28, 2019. In October 2022, the EMA's Committee for Medicinal Products for Human Use (CHMP) recommended cemiplimab be granted marketing authorization for the treatment of cervical cancer.

Background

Cemiplimab is a fully human monoclonal antibody that works against programmed death receptor-1 (PD-1), which is a negative regulator of T cell function. By blocking PD-1, cemiplimab works to enhance T cell-mediated antitumour responses. Cemiplimab was first approved by the FDA on September 28, 2018, as the first FDA-approved treatment for advanced cutaneous squamous cell carcinoma (CSCC). It was later approved to be used in basal cell carcinoma and non-small non-small cell lung cancer. Cemiplimab was also approved by the European Commission on June 28, 2019. In October 2022, the EMA's Committee for Medicinal Products for Human Use (CHMP) recommended cemiplimab be granted marketing authorization for the treatment of cervical cancer.

Indication

Cemiplimab is indicated to treat:

Associated Conditions

  • Locally Advanced Basal Cell Carcinoma
  • Locally Advanced Cutaneous Squamous Cell Carcinoma
  • Locally Advanced Non-Small Cell Lung Cancer
  • Metastatic Cervical Cancer
  • Metastatic Non-Small Cell Lung Cancer
  • Metastatic cutaneous squamous cell carcinoma
  • Recurrent Cervical Cancer
  • Metastatic Basal cell carcinoma

FDA Approved Products

LIBTAYO
Manufacturer:Regeneron Pharmaceuticals, Inc.
Route:INTRAVENOUS
Strength:50 mg in 1 mL
Approved: 2024/03/04
NDC:61755-008

Singapore Approved Products

No Singapore products found for this drug

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