Retifanlimab
Highest phase reached
Approved
Drug type
Antibody
First approval year
2023
- First approval year
- 2023
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody
- Drug name
- Retifanlimab
- zynyz
- Zynyz
- aex 1188
- AEX-1188
- aex1188
- AEX1188
- anti pd 1 monoclonal antibody mga012
- ANTI-PD-1 MONOCLONAL ANTIBODY MGA012
- immunoglobulin g4 anti human programmed cell death protein 1 humanized monoclonal mga012 gamma 4 chain disulfide with humanized monoclonal mga012 kappa chain dimer
- immunoglobulin g4 kappa anti homo sapiens programmed cell death protein 1 protein pd 1cd279 antigen monoclonal antibody gamma 4 heavy chain humanized 1 445 vh homo sapiens ighv1 46 01 82 ighd ighj4 01 93 8 8 12 1 119 homo sapiens ighg4 01 hinge s10 p 227 ch3 k107 del 446 120 445 133 218 disulfide with kappa light chain chimeric 1 218 v kappa mus musculus igkv3 2 01 81 igkj2 01 92 homo sapiens igkv3d 11 02 78 igkj4 01 100 10 3 9 1 111 homo sapiens igkc 01 112 218 dimer 225 225 228 228 bisdisulfide
- IMMUNOGLOBULIN G4-KAPPA, ANTI-(HOMO SAPIENS PROGRAMMED CELL DEATH PROTEIN 1 (PROTEIN PD-1CD279 ANTIGEN))MONOCLONAL ANTIBODY.GAMMA.4 HEAVY CHAIN HUMANIZED (1-445) (VH (HOMO SAPIENS IGHV1-46*01 (82%) (IGHD)-IGHJ4*01 (93%)) (8.8.12) (1-119)-HOMO SAPIENS IGHG4*01 (HINGE (S10>P(227)),CH3(K107>DEL(446))) (120-445)) (133-218')-DISULFIDE WITH .KAPPA. LIGHT CHAIN CHIMERIC (1'-218') (V-KAPPA (MUS MUSCULUS IGKV3-2*01 (81%) IGKJ2*01 (92%))/(HOMO SAPIENS IGKV3D-11*02 (78%) IGKJ4*01 (100%))(10.3.9) (1'-111')-HOMO SAPIENS IGKC*01 (112'-218')), DIMER (225-225'':228-228'')-BISDISULFIDE
- IMMUNOGLOBULIN G4, ANTI-(HUMAN PROGRAMMED CELL DEATH PROTEIN 1) (HUMANIZED MONOCLONAL MGA012 .GAMMA.4-CHAIN), DISULFIDE WITH HUMANIZED MONOCLONAL MGA012 .KAPPA.-CHAIN, DIMER
- incmga 00012
- incmga 0012
- INCMGA-00012
- INCMGA-0012
- incmga00012
- Incmga00012
- INCMGA00012
- INCMGA00012 (PD-1 antibody)
- incmga00012 pd 1 antibody
- INCMGA00012.
- mga 012
- MGA-012
- mga012
- Mga012
- MGA012
And 14 more, listed on the interactive page.
- CAS registry numbers
- 2079108-44-2
- ChEMBL ID
- CHEMBL4298037
- FDA ingredient codes (UNII)
- 2Y3T5IF01Z
- L01FF10
- L01FX06
Sources for recorded values
- 2632980
- 2632981
- Applicant
- INCYTE CORP
- Approval date
- 22 Mar 2023
- Application number
- BLA761334
- Status
- Authorised
- Status date
- 19 Apr 2024
- Authorisation date
- 19 Apr 2024
- Approved indications
- Squamous cell carcinoma of the anal canal (SCAC) Zynyz is indicated in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with metastatic or with inoperable locally recurrent squamous cell carcinoma of the anal canal (SCAC). Merkel cell carcinoma (MCC) Zynyz is indicated as monotherapy for the first line treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) not amenable to curative surgery or radiation therapy.
- Product number
- EMEA/H/C/006194
- Authorisation holder
- Incyte Biosciences Distribution B.V.
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- Yes
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Carcinoma, Merkel Cell
European medicines record
- Patents
- 0
- Designations
- 4
- Earliest recorded loss of exclusivity
- 24 Apr 2034
- First in class
- No
- Fast track
- Yes
- Breakthrough designation
- No
- Orphan designation
- Yes
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- Yes
- Availability
- Prescription only
- Pharmacology name
- retifanlimab
- Type
- Antibody
- Drug name stem
- -mab
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Mechanism
- Programmed cell death protein 1 antagonist
- Action type
- Antagonist
- Target
- Programmed cell death protein 1
- Protein identifier
- Q15116
- Action
- Binding
- Action type
- Binding
- Target
- programmed cell death 1 (CD279)
- Gene symbol
- PDCD1
- Protein identifier
- Q15116
- Median affinity
- 8.82
- Affinity units
- pKd
Open Targets mechanisms
- Mechanism
- Programmed cell death protein 1 antagonist
- Action type
- Antagonist
- Target
- Programmed cell death protein 1
- Condition
- Carcinoma, Squamous Cell
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000181
- Subject identifier
- D002294
- Condition
- Breast Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000305
- Subject identifier
- D001943
- Condition
- Glioblastoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000519
- Subject identifier
- D005909
- Condition
- Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- Condition
- Sarcoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000691
- Subject identifier
- D012509
- Condition
- Carcinoma, Squamous Cell
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000707
- Subject identifier
- D002294
- Condition
- Melanoma
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000756
- Subject identifier
- D008545
- 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
- Breast Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003869
- Subject identifier
- D001943
- Condition
- Triple Negative Breast Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0005537
- Subject identifier
- D064726
- Condition
- Head and Neck Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0006859
- Subject identifier
- D006258
- Condition
- Urinary Bladder Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0008528
- Subject identifier
- D001749
- Condition
- Paraganglioma
- Highest recorded phase
- 2
- Condition identifier
- EFO:1000453
- Subject identifier
- D010235
- Condition
- Malignant Carcinoid Syndrome
- Highest recorded phase
- 2
- Condition identifier
- EFO:1000852
- Subject identifier
- D008303
- Condition
- Carcinoma, Merkel Cell
- Highest recorded phase
- 4
- Condition identifier
- EFO:1001471
- Subject identifier
- D015266
- Condition
- Neuroendocrine Tumors
- Highest recorded phase
- 2
- Condition identifier
- EFO:1001901
- Subject identifier
- D018358
- Condition
- Sarcoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:1001968
- Subject identifier
- D012509
- Condition
- Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- MONDO:0004992
- Subject identifier
- D009369
- Condition
- Carcinoma, Pancreatic Ductal
- Highest recorded phase
- 1
- Condition identifier
- MONDO:0005184
- Subject identifier
- D021441
- Condition
- Breast Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0007254
- Subject identifier
- D001943
- Condition
- Esophageal Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0007576
- Subject identifier
- D004938
- Condition
- Endometrial Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0011962
- Subject identifier
- D016889
- Condition identifier
- EFO_0000305
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000519
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000616
- Condition identifier
- EFO_0000707
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000756
- Condition identifier
- EFO_0002618
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003060
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003085
- Highest recorded phase
- 2
- Condition identifier
- EFO_0005537
- Highest recorded phase
- 2
- Condition identifier
- EFO_0008528
- Highest recorded phase
- 2
- Condition identifier
- EFO_1001471
- Condition identifier
- EFO_1001471
- Highest recorded phase
- 4
- Condition identifier
- EFO_1001480
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0000448
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0001056
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0001325
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0002120
- Condition identifier
- MONDO_0002120
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0002974
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0003046
- Condition identifier
- MONDO_0003199
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0003219
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0004986
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0004992
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0004992
- Highest recorded phase
- 3
And 37 more, listed on the interactive page.
- Event
- bladder wall calcification
- Reports
- 1
- Reporting signal score
- 9.7345
- Event
- tri-iodothyronine free decreased
- Reports
- 1
- Reporting signal score
- 8.04359
- Event
- venous angioma of brain
- Reports
- 1
- Reporting signal score
- 8.89828
- NCT03059823
- NCT04949191
- NCT03328026
- NCT03406949
- NCT03522142
- NCT03589651
- NCT03910530
- NCT06179160
- NCT06320405
- NCT03532295
- NCT03597295
- NCT03599713
- NCT05594290
- NCT06056895
- NCT03920839
- NCT04203511
- NCT04205812
- NCT04116073
- NCT04129320
- NCT04470024
- NCT05287113
- NCT04225039
- NCT05083754
- NCT05743595
- NCT04370704
And 9 more, listed on the interactive page.
- Dose
- 500 mg or 375 mg
- Route
- Intravenous
- How often
- Every 3 or 4 weeks
- Administer as infusion over 30 minutes
- Administer within 8 hours at room temperature or 24 hours refrigerated
- Dilute with 0.9% Sodium Chloride Injection or 5% Dextrose Injection to 1.4-10 mg/mL
- Discard if discolored or particulate matter present
- Do not shake or freeze
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Heavy chain
- Type
- Protein
- Sequence
- QVQLVQSGAEVKKPGASVKVSCKASGYSFTSYWMNWVRQAPGQGLEWIGVIHPSDSETWLDQKFKDRVTITVDKSTSTAYMELSSLRSEDTAVYYCAREHYGTSPFAYWGQGTLVTVSSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTKTYTCNVDHKPSNTKVDKRVESKYGPPCPPCPAPEFLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPPSQEEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQEGNVFSCSVMHEALHNHYTQKSLSLSLG
- Component
- Light chain
- Type
- Protein
- Sequence
- EIVLTQSPATLSLSPGERATLSCRASESVDNYGMSFMNWFQQKPGQPPKLLIHAASNQGSGVPSRFSGSGSGTDFTLTISSLEPEDFAVYFCQQSKEVPYTFGGGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
- Component
- Glycosylation sites (N)
- Sequence
- Asn-296 $ Asn-296''''
- Component
- Disulfide bridges
- Sequence
- 138'-198' $ 138'''-198''' $ 146-202 $ 146''-202'' $ 225-225'' $ 228-228'' $ 260-320 $ 260''-320'' $ 366-424 $ 366''-424''
- Component
- Glycosylation sites (N)
- Sequence
- Asn-296 $ Asn-296''
- 50881-006
Related records
Trials (70)
- 9-ING-41 Combined With Retifanlimab, Plus Modified FOLFIRINOX for Patients With Advanced Pancreatic Adenocarcinoma (RiLEY)
- 9-ING-41 Plus Retifanlimab and Gemcitabine/Nab-Paclitaxel in Patients With Advanced Pancreatic Adenocarcinoma
- A Phase 1 Study of INCMGA00012 in Patients With Advanced Solid Tumors
- A Phase 2, Open Label Study of PEmigatinib and REtifanlimab in Advanced Dedifferentiated LIposarcoma (PERELI)
- A Phase Ib Study of Novel Combination (New) of Low Dose Oral CyclophoSphamide (s) to Potentiate Axatilimab (A) + Retifanlimab (R) in Treating Metastatic Triple Negative Breast Cancer (TNBC)
- A Study Exploring the Safety and Tolerability of INCB081776 in Participants With Advanced Malignancies
- A Study of INCMGA00012 in Metastatic Merkel Cell Carcinoma (POD1UM-201)
- A Study of INCMGA00012 in Participants With Selected Solid Tumors (POD1UM-203)
- A Study of INCMGA00012 in Squamous Carcinoma of the Anal Canal Following Platinum-Based Chemotherapy (POD1UM-202)
- A Study of INCMGA00012, INCB001158, and the Combination in Japanese Participants With Advanced Solid Tumors
- A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation
- A Study to Evaluate INCB177054 in Participants With Select Advanced or Metastatic Solid Tumors
- A Trial to Evaluate CSF ctDNA and Safety of Plixorafenib Alone or With Retifanlimab in Patients With BRAF-altered Glioma
- All-Trans Retinoic Acid (ATRA) Plus PD-1 Inhibition in Recurrent IDH-Mutant Glioma
- An Early Access Program Guideline to Provide Access to Retifanlimab (INCMGA00012) Together With Carboplatin and Paclitaxel for Squamous Carcinoma of the Anal Canal (SCAC)
- An Umbrella Study to Determine the Safety and Efficacy of Various Monotherapy or Combination Therapies in Neoadjuvant Urothelial Carcinoma
- Anti-GITR/Anti-PD1/Stereotactic Radiosurgery, in Recurrent Glioblastoma
- Anti-PD-1 and CapOx for the First-line Treatment of dMMR Esophagogastric Cancer (AuspiCiOus)
- ASTX727 & Retifanlimab-dlwr for Advanced Merkel Cell After Progression on Anti-PD-(L)1
- Axatilimab in Combination With Retifanlimab and Paclitaxel for the Treatment of Patients With Advanced or Metastatic Solid Tumors
Approved for (5)
- Cancer
- Cutaneous neuroendocrine carcinoma
- Head and neck squamous cell carcinoma
- Neoplasm
- Squamous cell carcinoma
In development for (20)
- Breast cancer Phase 2
- Breast carcinoma Phase 2
- Breast neoplasm Phase 2
- Carcinoid syndrome Phase 2
- Dedifferentiated liposarcoma Phase 2
- Endometrial cancer Phase 2
- Esophageal cancer Phase 2
- Exocrine pancreatic carcinoma Phase 2
- Glioblastoma Phase 2
- Head and neck cancer Phase 2
- Melanoma Phase 1
- Neuroendocrine neoplasm Phase 2
- Non-small cell lung carcinoma Phase 3
- Pancreatic ductal adenocarcinoma Phase 1
- Paraganglioma Phase 2
- Penile cancer Phase 2
- Sarcoma Phase 2
- Soft tissue sarcoma Phase 2
- Triple-negative breast carcinoma Phase 2
- Urothelial carcinoma Phase 2
Other linked conditions (1)
Targets (1)
- PDCD1 Programmed cell death protein 1 antagonist