Cemiplimab

ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS

Key facts

Cemiplimab is a drug catalogued in DrugCentral. It was first approved by the FDA in 2018. DrugCentral lists 1 molecular target, including PDCD1. Recorded indications include Malignant tumor of cervix, Metastatic basal cell carcinoma, Non-small cell lung cancer without mutation in epidermal growth factor receptor and Nonsmall cell lung cancer without mutation in epidermal growth factor receptor.

• Molecular targets: PDCD1 (1 listed in DrugCentral).
• Indications: Malignant tumor of cervix, Metastatic basal cell carcinoma, Non-small cell lung cancer without mutation in epidermal growth factor receptor, Nonsmall cell lung cancer without mutation in epidermal growth factor receptor and Squamous cell carcinoma.
• ATC code: L01FF06 (PD-1/PD-L1 (Programmed cell death protein 1/death ligand 1) inhibitors).

Indications & contraindications

Drug–disease relationships curated by DrugCentral (OMOP / SNOMED concepts).

Indications (5)

• Malignant tumor of cervix
• Metastatic basal cell carcinoma
• Non-small cell lung cancer without mutation in epidermal growth factor receptor
• Nonsmall cell lung cancer without mutation in epidermal growth factor receptor
• Squamous cell carcinoma

Mechanism & targets

Molecular targets (1)

Target	Gene	Action	Activity
Programmed cell death protein 1	PDCD1	other	Kd 7.10

Regulatory approvals (3)

Date	Agency	Marketed as	Applicant	Orphan
2022-12-23	PMDA	—	Sanofi K.K.
2019-06-28	EMA	—	REGENERON IRELAND U.C.
2018-09-28	FDA	—	REGENERON PHARMACEUTICALS

ATC classification

ATC code	Therapeutic hierarchy
L01FF06	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS › ANTINEOPLASTIC AGENTS › MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES › PD-1/PD-L1 (Programmed cell death protein 1/death ligand 1) inhibitors

Reported adverse-event signals

Strongest FDA FAERS disproportionality signals (log-likelihood ratio). A signal is a statistical association in spontaneous reports, not proof that the drug causes the event.

MedDRA term	LLR
Disease progression	257.8
Myocarditis	207.2
Pneumonitis	149.2
Pemphigoid	116.2
Myositis	116.1
Adrenal insufficiency	80.7
Cholangitis	79.1
Death	78.4
Immune-mediated hepatitis	77.5
Colitis	76.0
Squamous cell carcinoma of skin	70.3
Interstitial lung disease	68.7

Chemical structure

• Molecular formula: —
• Molecular weight: —
• CAS number: 1801342-60-8
• InChIKey: —
• PubChem CID: —

Frequently asked questions

Answers are generated from the structured data on this page, not written by hand.

What is Cemiplimab used for?

DrugCentral lists the following indications for Cemiplimab: Malignant tumor of cervix, Metastatic basal cell carcinoma, Non-small cell lung cancer without mutation in epidermal growth factor receptor, Nonsmall cell lung cancer without mutation in epidermal growth factor receptor and Squamous cell carcinoma.

How does Cemiplimab work?

Its molecular targets in DrugCentral include PDCD1.

When was Cemiplimab first approved?

Cemiplimab was first approved by the FDA in 2018.

Sources

• DrugCentral drug card 5317 — structure, indications, targets, approvals, pharmacologic classes (CC BY-SA 4.0)
• ChEMBL CHEMBL4297723 — compound record and bioactivity
• DrugBank DB14707 — drug record
• FDA UNII 6QVL057INT — substance identity
• DailyMed: FDA labels for Cemiplimab — current prescribing information (label search)
• UniProt Q15116 (PDCD1) — target protein
• FDA Adverse Event Reporting System (openFDA FAERS) — adverse-event signals, as aggregated by DrugCentral

How this page is built: methodology · editorial policy & corrections.