Cemiplimab
Highest phase reached
Approved
Drug type
Antibody
First approval year
2018
- First approval year
- 2018
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody
- Drug name
- Cemiplimab
- libtayo
- Libtayo
- 350 mg cemiplimab
- 350 mg Cemiplimab
- cemiplimab
- Cemiplimab
- cemiplimab (maintenance)
- Cemiplimab (maintenance)
- cemiplimab (monotherapy)
- Cemiplimab (SAR439684)
- cemiplimab [INN]
- CEMIPLIMAB [JAN]
- CEMIPLIMAB [MI]
- CEMIPLIMAB [USAN]
- Cemiplimab [WHO-DD]
- Cemiplimab 350 MG Intravenous Solution
- Cemiplimab 350 mg IV
- cemiplimab inn
- cemiplimab jan
- cemiplimab mi
- cemiplimab rwlc
- Cemiplimab rwlc
- Cemiplimab rwlc [WHO-DD]
- cemiplimab rwlc purple book cder
- cemiplimab rwlc who dd
- cemiplimab usan
- cemiplimab who dd
And 10 more, listed on the interactive page.
- CAS registry numbers
- 1801342-60-8
- ChEMBL ID
- CHEMBL4297723
- FDA ingredient codes (UNII)
- 6QVL057INT
- L01FF06
- L01XC33
Sources for recorded values
- 2058825
- 2058826
- Applicant
- REGENERON PHARMACEUTICALS
- Approval date
- 28 Sept 2018
- Application number
- BLA761097
- Status
- Authorised
- Status date
- 28 Jun 2019
- Authorisation date
- 28 Jun 2019
- Approved indications
- Cutaneous Squamous Cell Carcinoma Libtayo as monotherapy is indicated for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (mCSCC or laCSCC) who are not candidates for curative surgery or curative radiation. Libtayo as monotherapy is indicated for the adjuvant treatment of adult patients with CSCC at high risk of recurrence after surgery and radiation (see section 5.1 for selection criteria). Basal Cell Carcinoma Libtayo as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic basal cell carcinoma (laBCC or mBCC) who have progressed on or are intolerant to a hedgehog pathway inhibitor (HHI). Non-Small Cell Lung Cancer Libtayo as monotherapy is indicated for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) expressing PD-L1 (in ? 50% tumour cells), with no EGFR, ALK or ROS1 aberrations, who have: locally advanced NSCLC who are not candidates for definitive chemoradiation, or metastatic NSCLC. Libtayo in combination with platinum?based chemotherapy is indicated for the first?line treatment of adult patients with NSCLC expressing PD-L1 (in ? 1% of tumour cells), with no EGFR, ALK or ROS1 aberrations, who have: locally advanced NSCLC who are not candidates for definitive chemoradiation, or metastatic NSCLC. Cervical Cancer Libtayo as monotherapy is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy.
- Product number
- EMEA/H/C/004844
- Authorisation holder
- Regeneron Ireland Designated Activity Company (DAC)
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Carcinoma, Squamous Cell
European medicines record
- Patents
- 0
- Designations
- 5
- First in class
- No
- Fast track
- No
- Breakthrough designation
- Yes
- Orphan designation
- No
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- No
- Pharmacology name
- cemiplimab
- Type
- Antibody
- Drug name stem
- -mab
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Action
- Binding
- Action type
- Binding
- Target
- programmed cell death 1 (CD279)
- Gene symbol
- PDCD1
- Protein identifier
- Q15116
- Median affinity
- 8.21
- Affinity units
- pKd
- Primary target
- Yes
- Mechanism
- Programmed cell death protein 1 inhibitor
- Action type
- Inhibitor
- Target
- Programmed cell death protein 1
- Protein identifier
- Q15116
Open Targets mechanisms
- Mechanism
- Programmed cell death protein 1 inhibitor
- Action type
- Inhibitor
- Target
- Programmed cell death protein 1
- Condition
- Lymphoma, Follicular
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000096
- Subject identifier
- D008224
- Condition
- Carcinoma, Squamous Cell
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000181
- Subject identifier
- D002294
- Condition
- Hodgkin Disease
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000183
- Subject identifier
- D006689
- Condition
- Glioblastoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000519
- Subject identifier
- D005909
- Condition
- Lymphoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000574
- Subject identifier
- D008223
- Condition
- Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- Condition
- Carcinoma, Renal Cell
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000681
- Subject identifier
- D002292
- Condition
- Carcinoma, Squamous Cell
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000707
- Subject identifier
- D002294
- Condition
- Melanoma
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000756
- Subject identifier
- D008545
- Condition
- HIV Infections
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000764
- Subject identifier
- D015658
- Condition
- Multiple Myeloma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0001378
- Subject identifier
- D009101
- Condition
- Pancreatic Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0002618
- Subject identifier
- D010190
- Condition
- Carcinoma, Non-Small-Cell Lung
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003060
- Subject identifier
- D002289
- Condition
- Liposarcoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003085
- Subject identifier
- D008080
- Condition
- Urogenital Neoplasms
- Highest recorded phase
- 1
- Condition identifier
- EFO:0003863
- Subject identifier
- D014565
- Condition
- Breast Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003869
- Subject identifier
- D001943
- Condition
- Hemangiosarcoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003968
- Subject identifier
- D006394
- Condition
- Carcinoma, Basal Cell
- Highest recorded phase
- 4
- Condition identifier
- EFO:0004193
- Subject identifier
- D002280
- Condition
- Hepatitis B, Chronic
- Highest recorded phase
- 1
- Condition identifier
- EFO:0004197
- Subject identifier
- D019694
- Condition
- Head and Neck Neoplasms
- Highest recorded phase
- 1
- Condition identifier
- EFO:0006859
- Subject identifier
- D006258
- Condition
- Neoplasm Metastasis
- Highest recorded phase
- 1
- Condition identifier
- EFO:0009709
- Subject identifier
- D009362
- Condition
- Diffuse Intrinsic Pontine Glioma
- Highest recorded phase
- 1
- Condition identifier
- EFO:1000026
- Subject identifier
- D000080443
- Condition
- Mycosis Fungoides
- Highest recorded phase
- 1
- Condition identifier
- EFO:1001051
- Subject identifier
- D009182
- Condition
- Carcinoma, Merkel Cell
- Highest recorded phase
- 2
- Condition identifier
- EFO:1001471
- Subject identifier
- D015266
- Condition
- Stomach Neoplasms
- Highest recorded phase
- 1
- Condition identifier
- MONDO:0001056
- Subject identifier
- D013274
And 12 more, listed on the interactive page.
- Condition identifier
- EFO_0000181
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000183
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000519
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000574
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000616
- Condition identifier
- EFO_0000681
- Condition identifier
- EFO_0000707
- Condition identifier
- EFO_0000756
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000764
- Condition identifier
- EFO_0001378
- Highest recorded phase
- 2
- Condition identifier
- EFO_0002618
- Highest recorded phase
- 2
- Condition identifier
- EFO_0002921
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003060
- Condition identifier
- EFO_0003863
- Highest recorded phase
- 1
- Condition identifier
- EFO_0004193
- Condition identifier
- EFO_0004197
- Condition identifier
- EFO_0009709
- Highest recorded phase
- 1
- Condition identifier
- EFO_1000796
- Highest recorded phase
- 2
- Condition identifier
- EFO_1001051
- Condition identifier
- EFO_1001471
- Highest recorded phase
- 1
- Condition identifier
- EFO_1001471
- Highest recorded phase
- 2
- Condition identifier
- EFO_1001927
- Condition identifier
- EFO_1001927
- Highest recorded phase
- 4
- Condition identifier
- EFO_1001950
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0000430
- Highest recorded phase
- 1
And 83 more, listed on the interactive page.
- Event
- acute kidney injury
- Reports
- 22
- Reporting signal score
- 17.6233
- Event
- adrenal insufficiency
- Reports
- 11
- Reporting signal score
- 26.8574
- Event
- adrenocorticotropic hormone deficiency
- Reports
- 2
- Reporting signal score
- 7.25613
- Event
- autoimmune myocarditis
- Reports
- 2
- Reporting signal score
- 9.5759
- Event
- autoimmune myositis
- Reports
- 2
- Reporting signal score
- 9.26462
- Event
- autoimmune nephritis
- Reports
- 2
- Reporting signal score
- 8.72185
- Event
- autoimmune pericarditis
- Reports
- 2
- Reporting signal score
- 13.4908
- Event
- cholestasis
- Reports
- 10
- Reporting signal score
- 15.9457
- Event
- colitis
- Reports
- 10
- Reporting signal score
- 13.4055
- Event
- cytokine release syndrome
- Reports
- 8
- Reporting signal score
- 18.5202
- Event
- dermatitis
- Reports
- 5
- Reporting signal score
- 7.50245
- Event
- dermatitis bullous
- Reports
- 6
- Reporting signal score
- 12.046
- Event
- dizziness
- Reports
- 1
- Reporting signal score
- 8.06867
- Event
- encephalitis
- Reports
- 5
- Reporting signal score
- 11.1483
- Event
- hepatitis
- Reports
- 15
- Reporting signal score
- 27.3408
- Event
- hepatocellular injury
- Reports
- 13
- Reporting signal score
- 23.1026
- Event
- hypercalcaemia
- Reports
- 5
- Reporting signal score
- 7.30405
- Event
- hypophysitis
- Reports
- 4
- Reporting signal score
- 11.2398
- Event
- hypothyroidism
- Reports
- 8
- Reporting signal score
- 11.265
- Event
- hypovolaemic shock
- Reports
- 7
- Reporting signal score
- 20.9869
- Event
- immune-mediated hepatitis
- Reports
- 9
- Reporting signal score
- 40.4995
- Event
- immune-mediated lung disease
- Reports
- 2
- Reporting signal score
- 8.02167
- Event
- immune-mediated pneumonitis
- Reports
- 4
- Reporting signal score
- 19.246
- Event
- infusion related reaction
- Reports
- 16
- Reporting signal score
- 19.5872
- Event
- infusion site extravasation
- Reports
- 4
- Reporting signal score
- 7.86217
And 15 more, listed on the interactive page.
- NCT01042379
- NCT04243616
- NCT04916002
- NCT05064085
- NCT05259696
- NCT02383212
- NCT02520245
- NCT03005782
- NCT03233139
- NCT02651662
- NCT03002376
- NCT04526899
- NCT05352672
- NCT05608291
- NCT06190951
- NCT06246916
- NCT03088540
- NCT03409614
- NCT03515629
- NCT03580694
- NCT04982224
- NCT05142189
- NCT05208944
- NCT05344209
- NCT05401786
And 59 more, listed on the interactive page.
- Dose
- 350 mg
- Route
- Intravenous
- How often
- Every 3 weeks until disease progression or unacceptable toxicity, or up to 24 months
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Disulfide bridges location
- Sequence
- 22-96$22''-96''$23'-88'$23'''-88'''$131-214'$131''-214'''$134'-194'$134'''-194'''$144-200$144''-200''$223-223''$226-226''$258-318$258''-318''$364-422$364''-422''A(tm)
- Component
- Light chain
- Type
- Protein
- Sequence
- DIQMTQSPSSLSASVGDSITITCRASLSINTFLNWYQQKPGKAPNLLIYAASSLHGGVPSRFSGSGSGTDFTLTIRTLQPEDFATYYCQQSSNTPFTFGPGTVVDFRRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
- Component
- Heavy chain
- Type
- Protein
- Sequence
- EVQLLESGGVLVQPGGSLRLSCAASGFTFSNFGMTWVRQAPGKGLEWVSGISGGGRDTYFADSVKGRFTISRDNSKNTLYLQMNSLKGEDTAVYYCVKWGNIYFDYWGQGTLVTVSSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTKTYTCNVDHKPSNTKVDKRVESKYGPPCPPCPAPEFLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPPSQEEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQEGNVFSCSVMHEALHNHYTQKSLSLSLGK
- 61755-008
Related records
Trials (212)
- 5-Azacitidine Plus PD-1/PD-L1 Inhibitor With PD-1/PD-L1 Refractory Tumors
- A Clinical Study to Assess the Efficacy of Adjuvant Immunotherapy With Cemiplimab in Patients With Surgically Removed Non-small Cell Lung Cancer Who Have Not Received Prior Chemotherapy
- A Dose Escalation and Dose Expansion Study of Intratumoral ONM-501 Alone and in Combination With Cemiplimab in Patients With Advanced Solid Tumors and Lymphomas.
- A First-In Human (FIH) Study to Find Out How Well REGN10597 Medicine Given Alone or in Combination With Cemiplimab Works in Adult Participants Who Have Cancer With Tumors That Have Spread in Their Body
- A First-in-Human Dose Escalation and Expansion Study to Evaluate Intratumoral Administration of SAR441000 as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors
- A First-in-human Study of the Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of SAR439459 Monotherapy and Combination of SAR439459 and Cemiplimab in Patients With Advanced Solid Tumors
- A Multicenter Open-label Phase II Study of Cemiplimab Plus Chemotherapy, Selected on the Basis of Baseline Cytidine Deaminase Activity, in Advanced Squamous Non-small Cell Lung Cancer
- A Multicenter Phase 1b/2 Study of Adagrasib, Cetuximab, and Cemiplimab for Metastatic Colorectal Cancer Harboring KRAS G12C Mutations
- A PD-1 Checkpoint Inhibitor (Cemiplimab) for High-Risk Localized, Locally Recurrent, or Regionally Advanced Skin Cancer
- A Ph Ib Study of REGN5678 Plus Cemiplimab in Patients With mCRPC
- A Phase 1 Study of BHV-1530 in Advanced Solid Tumors
- A Phase 1/2 Study of BHV-1510 (Previously PBI-410) in Advanced Solid Tumors
- A Phase Ib Study to Evaluate the Safety and Preliminary Efficacy of IL6-receptor Antibody Sarilumab in Combination With antiPD1 Antibody Cemiplimab for Patients With Non-small Cell Lung Cancer.
- A Phase II Platform Study to Evaluate Treatment With Cemiplimab Monotherapy or Cemiplimab Plus Fianlimab or Other Novel Combinations in Patients With Colorectal Cancer With Minimal Residual Disease Following Definitive Surgery and Chemotherapy (EMPIRE)
- A PHASE II, RANDOMIZED STUDY TO ASSESS MAINTENANCE THERAPY WITH CEMIPLIMAB VERSUS BEST SUPPORTIVE CARE AFTER 1ST LINE PLATINUM-BASED CHEMOTHERAPY IN ADVANCED/RECURRENT PENILE CANCER
- A PHASE II, RANDOMIZED TRIAL TO ASSESS MAINTENANCE THERAPY WITH CEMIPLIMAB VERSUS BEST SUPPORTIVE CARE AFTER 1ST LINE PLATINUM-BASED CHEMOTHERAPY IN ADVANCED/RECURRENT VULVAR CANCER
- A Phase III Study With THIO + Cemiplimab vs Chemotherapy as 3rd Line Treatment in Advanced/Metastatic NSCLC
- A Randomized Phase 2 Study of Cemiplimab ± ISA101b in HPV16-Positive OPC
- A Randomized Phase II Trial of Cemiplimab Plus OSE2101 ( TEDOPI®) as Maintenance Therapy in ctDNA Positive NSCL. The Cemited Study.
- A Randomized Trial of Fianlimab and Cemiplimab +/- Ipilimumab or Ipilimumab Plus Nivolumab in First-line Advanced Renal Cell Carcinoma (RCC)
Approved for (6)
- Basal cell carcinoma
- Cancer
- Head and neck squamous cell carcinoma
- Lung cancer
- Neoplasm
- Squamous cell carcinoma
In development for (36)
- Adrenal cortex carcinoma Phase 2
- Angiosarcoma Phase 2
- Breast cancer Phase 2
- Breast neoplasm Phase 2
- Cervical cancer Phase 3
- Colon carcinoma Phase 2
- Colorectal cancer Phase 2
- Cutaneous neuroendocrine carcinoma Phase 2
- Dedifferentiated liposarcoma Phase 2
- Diffuse intrinsic pontine glioma Phase 1
- Exocrine pancreatic carcinoma Phase 2
- Fallopian tube cancer Phase 1
- Gastric cancer Phase 1
- Glioblastoma Phase 2
- Head and neck cancer Phase 1
- Hepatitis B virus infection Phase 1
- HIV infectious disease Phase 1
- Hodgkins lymphoma Phase 2
- Human papillomavirus-related squamous cell carcinoma Phase 2
- Lymphoma Phase 2
Targets (1)
- PDCD1 Programmed cell death protein 1 inhibitor