Retifanlimab

Retifanlimab
Monoclonal antibody
Type	Whole antibody
Source	Humanized
Target	Programmed cell death protein 1 (PD-1)
Clinical data
Trade names	Zynyz
Other names	AEX-1188, INCMGA-00012, MGA-012, retifanlimab-dlwr
AHFS/Drugs.com	Zynyz
MedlinePlus	a623017
License data	US DailyMed: Retifanlimab
Routes of administration	Intravenous
ATC code	L01FF10 (WHO)
Legal status
Legal status	US: ℞-only^[1]
Identifiers
CAS Number	2079108-44-2
DrugBank	DB15766
UNII	2Y3T5IF01Z
KEGG	D11827
Chemical and physical data
Formula	C₆₄₅₆H₉₉₃₄N₁₇₀₂O₂₀₃₂S₄₆
Molar mass	145381.13 g·mol⁻¹

Retifanlimab, sold under the brand name Zynyz, is an anti-cancer medication used for the treatment of Merkel cell carcinoma.^[1] Retifanlimab is a programmed death receptor-1 (PD-1)–blocking monoclonal antibody.^[1]

It was approved for medical use in the United States in March 2023.^[1]^[2]^[3]^[4]^[5]

Medical uses

Retifanlimab is indicated for the treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma.^[1]^[2]^[6]

History

The US Food and Drug Administration (FDA) evaluated the safety and efficacy of retifanlimab based on PODIUM-201 (NCT03599713), an open-label, multiregional, single-arm study evaluating 65 participants with metastatic or recurrent locally advanced MCC who had not received prior systemic therapy for advanced disease.^[2]

The FDA granted the application for retifanlimab priority review, fast track, and orphan drug designations.^[2]

Society and culture

Legal status

In February 2024, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Zynyz, intended for the treatment of Merkel cell carcinoma.^[7] The applicant for this medicinal product is Incyte Biosciences Distribution B.V.^[7]

Names

Retifanlimab is the international nonproprietary name.^[8]

References

^ ^a ^b ^c ^d ^e "Zynyz- retifanlimab-dlwr injection". DailyMed. 22 March 2023. Archived from the original on 1 July 2023. Retrieved 20 November 2023.
^ ^a ^b ^c ^d "FDA grants accelerated approval to retifanlimab-dlwr for metastatic or recurrent locally advanced Merkel cell carcinoma". U.S. Food and Drug Administration (FDA). 22 March 2023. Archived from the original on 23 March 2023. Retrieved 22 March 2023. This article incorporates text from this source, which is in the public domain.
^ "Incyte Announces FDA Approval of Zynyz (retifanlimab-dlwr) for the Treatment of Metastatic or Recurrent Locally Advanced Merkel Cell Carcinoma (MCC)" (Press release). Incyte. 22 March 2023. Archived from the original on 23 March 2023. Retrieved 22 March 2023 – via Business Wire.
^ "MacroGenics Earns $15 Million Milestone Following U.S. FDA Approval of Zynyz (retifanlimab-dlwr)" (Press release). MacroGenics. 22 March 2023. Archived from the original on 23 March 2023. Retrieved 22 March 2023 – via GlobeNewswire.
^ Kang C (June 2023). "Retifanlimab: First Approval". Drugs. 83 (8): 731–737. doi:10.1007/s40265-023-01884-7. PMID 37184754. S2CID 258687035.
^ "Drug Approval Package: Zynyz". U.S. Food and Drug Administration (FDA). 19 April 2023. Archived from the original on 20 November 2023. Retrieved 20 November 2023.
^ ^a ^b "Zynyz EPAR". European Medicines Agency (EMA). 22 February 2024. Retrieved 24 February 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
^ World Health Organization (2020). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 83". WHO Drug Information. 34 (1). hdl:10665/339768.

External links

Clinical trial number NCT03599713 for "A Study of INCMGA00012 in Metastatic Merkel Cell Carcinoma (POD1UM-201)" at ClinicalTrials.gov

Targeted cancer therapy / antineoplastic agents (L01)

CI monoclonal antibodies ("-mab")

Receptor tyrosine kinase	ErbB: HER1/EGFR (Cetuximab Panitumumab) HER2/neu (Pertuzumab Trastuzumab (+hyaluronidase) Trastuzumab emtansine Trastuzumab deruxtecan Zanidatamab )
Others for solid tumors	EpCAM (Catumaxomab Edrecolomab) VEGF-A (Bevacizumab)
Leukemia/lymphoma	lymphoid: CD3 (Glofitamab, Elranatamab, Mosunetuzumab), CD20 (Glofitamab Ibritumomab Mosunetuzumab Obinutuzumab Ofatumumab Rituximab Tositumomab), CD30 (Brentuximab), CD52 (Alemtuzumab) myeloid: CD33 (Gemtuzumab ozogamicin)
Other	Amivantamab Atezolizumab (+hyaluronidase) Avelumab Axatilimab Belantamab mafodotin Bermekimab Blinatumomab Cemiplimab Daratumumab Dinutuximab beta Dostarlimab Durvalumab Elotuzumab Enfortumab vedotin Epcoritamab Inotuzumab ozogamicin Ipilimumab Isatuximab Loncastuximab tesirine Mirvetuximab soravtansine Mogamulizumab Moxetumomab pasudotox Naxitamab Necitumumab Nivolumab Olaratumab Oportuzumab monatox Pembrolizumab Polatuzumab vedotin Prolgolimab Ramucirumab Retifanlimab Sabatolimab Sacituzumab govitecan Serplulimab Sugemalimab Tafasitamab Talquetamab Tarlatamab Teclistamab Tislelizumab Tisotumab vedotin Toripalimab Tremelimumab Zolbetuximab

Tyrosine kinase inhibitors ("-nib")

Receptor tyrosine kinase

HER1/EGFR and HER2/neu

BRAF

RTK class III: C-kit and PDGFR (Avapritinib
Axitinib
Masitinib
Pazopanib
Ripretinib
Sorafenib
Sunitinib
Toceranib)
FLT3 (Lestaurtinib, Gilteritinib (AXL, ALK, LTK))

VEGFR
- Axitinib
- Cediranib
- Fruquintinib
- Lenvatinib
- Nintedanib
- Pazopanib
- Regorafenib
- Semaxanib
- Sorafenib
- Sunitinib
- Tivozanib
- Toceranib
- Vandetanib

ALK

RET inhibitors: Entrectinib (ALK, ROS1, NTRK), Futibatinib (FGFR2), Infigratinib, Larotrectinib (NTRK), Pemigatinib (FGFR), Pralsetinib, Repotrectinib (ROS1, TRK, ALK), Selpercatinib (VEGFR, FGFR), Vandetanib (VEGFR, EGFR).

c-MET inhibitors: Cabozantinib (VEGFR), Capmatinib, Crizotinib (ALK)

Non-receptor

bcr-abl
- Asciminib
- Bosutinib
- Dasatinib
- Imatinib
- Nilotinib
- Ponatinib
- Radotinib

Src (Bosutinib
Dasatinib)

Janus kinase (JAK)

MAP2K (MEK)

EML4-ALK

Bruton's (BTK)

Other

fusion protein against VEGF (Aflibercept)

proapoptotic peptide against ANXA2 and prohibitin (Adipotide)

exotoxin against IL-2 (Denileukin diftitox)

mTOR inhibitors

hedgehog inhibitors

CDK inhibitors

KRAS inhibitors
- Adagrasib
- Sotorasib

Pi3K inhibitors

Menin inhibitors
- Revumenib

Fibroblast growth factor receptor (FGFR) inhibitors
Erdafitinib
Futibatinib
Infigratinib
Pemigatinib

v t e PD-1 and PD-L1 inhibitors
PD-1 inhibitorsTooltip Programmed cell death protein 1	Nivolumab Pembrolizumab Cemiplimab Dostarlimab Retifanlimab Toripalimab
PD-L1 inhibitorsTooltip Programmed death-ligand 1	BMS-202 Atezolizumab Avelumab Durvalumab KN035 Cosibelimab AUNP12 CA-170 BMS-986189

Monoclonal antibodies for tumors

Tumor

Human	Adecatumumab^§ Amivantamab Ascrinvacumab^§ Atezolizumab (+hyaluronidase) Balstilimab^† Botensilimab Cixutumumab^§ Conatumumab^§ Daratumumab Drozitumab^§ Duligotumab^§ Dusigitumab^§ Enfortumab vedotin Enoticumab^§ Figitumumab^§ Flanvotumab^§ Ganitumab^† Glembatumumab vedotin^† Intetumumab^§ Ipilimumab Iratumumab^§ Istiratumab Icrucumab^§ Lexatumumab^§ Lucatumumab^§ Mapatumumab^§ Narnatumab^§ Necitumumab Nesvacumab^§ Nivolumab^# Ofatumumab Olaratumab^† Panitumumab Patritumab^§ Pembrolizumab^# Pritumumab^§ Radretumab^§ Ramucirumab Rilotumumab^† Robatumumab^§ Seribantumab^§ Sugemalimab Tarextumab^§ Tisotumab vedotin Teprotumumab^† Tovetumab^§ Vantictumab^§ Votumumab^§ Zalutumumab^†
Mouse	Abagovomab Altumomab pentetate Anatumomab mafenatox Arcitumomab Bectumomab Blinatumomab Capromab pendetide Detumomab Edrecolomab Ibritumomab tiuxetan Igovomab Lilotomab Minretumomab Mitumomab Nacolomab tafenatox Moxetumomab pasudotox Naptumomab estafenatox Oregovomab Pemtumomab^† Racotumomab Satumomab pendetide Solitomab Taplitumomab paptox Nofetumomab merpentan Pintumomab Tenatumomab Tositumomab
Chimeric	Amatuximab^§ Bavituximab^§ Brentuximab vedotin Carotuximab^† Cetuximab Derlotuximab biotin^§ Dinutuximab Ecromeximab^§ Ensituximab^§ Futuximab^§ Girentuximab^† Indatuximab ravtansine^§ Isatuximab Loncastuximab tesirine Margetuximab Mirvetuximab soravtansine Rituximab^# Siltuximab Ublituximab Zolbetuximab
Humanized	Abituzumab^§ Alemtuzumab Axatilimab Belantamab mafodotin Bevacizumab Bivatuzumab mertansine^§ Brontictuzumab^§ Cantuzumab mertansine^§ Cantuzumab ravtansine^§ Cirmtuzumab Citatuzumab bogatox^§ Clivatuzumab tetraxetan Cofetuzumab pelidotin Dacetuzumab^§ Demcizumab^§ Dalotuzumab^§ Denintuzumab mafodotin^§ Elotuzumab Emactuzumab Emibetuzumab^§ Enoblituzumab^§ Epcoritamab Etaracizumab^§ Farletuzumab^§ Ficlatuzumab^§ Flotetuzumab^§ Gemtuzumab ozogamicin Glofitamab Imgatuzumab^§ Inotuzumab ozogamicin Labetuzumab^§ Lifastuzumab vedotin^§ Lintuzumab^§ Lorvotuzumab mertansine^§ Lumretuzumab^§ Matuzumab^§ Milatuzumab^§ Naxitamab Nimotuzumab^† Obinutuzumab Ocaratuzumab^§ Odronextamab Otlertuzumab^§ Onartuzumab^§ Oportuzumab monatox^† Parsatuzumab^§ Pertuzumab Pinatuzumab vedotin^§ Polatuzumab vedotin Rosmantuzumab Rovalpituzumab tesirine^† Sacituzumab govitecan Sibrotuzumab^§ Simtuzumab^§ Sofituzumab vedotin^§ Tacatuzumab tetraxetan^§ Tigatuzumab^§ Trastuzumab^# (+deruxtecan / +emtansine) Tucotuzumab celmoleukin^§ Vandortuzumab vedotin^§ Vanucizumab^§ Veltuzumab^§ Vorsetuzumab mafodotin^§
Rat/mouse hybrid	Catumaxomab Ertumaxomab^§
Chimeric + humanized	Depatuxizumab mafodotin^† Duvortuxizumab Ontuxizumab^§

^#WHO-EM
^‡Withdrawn from market
Clinical trials:
- ^†Phase III
- ^§Never to phase III

Monoclonal antibodies for the immune system

Immune system

Human	Immunosuppression: Abrilumab Adalimumab^# Anifrolumab Atorolimumab Avelumab Avdoralimab Belimumab Bleselumab Brodalumab Camidanlumab tesirine Carlumab Cemiplimab Dupilumab Eldelumab Emapalumab Fresolimumab Golimumab Ianalumab^† Lanadelumab Lenzilumab Lerdelimumab Lirentelimab Lirilumab Mavrilimumab Metelimumab Morolimumab Namilumab Oleclumab Oxelumab§ Pamrevlumab Placulumab Relatlimab^† Sarilumab Sifalimumab Tabalumab Tezepelumab Ulocuplumab Varlilumab Immune activation: Ipilimumab Durvalumab Nivolumab Tremelimumab Urelumab Other: Bertilimumab Ontamalimab Zanolimumab Combination: Nivolumab/relatlimab
Mouse	Afelimomab Elsilimomab Faralimomab Gavilimomab Inolimomab Maslimomab Nerelimomab Odulimomab Telimomab aritox Vepalimomab Zolimomab aritox
Chimeric	Andecaliximab^† Basiliximab Clenoliximab Galiximab Gomiliximab Infliximab Keliximab Lumiliximab Priliximab Teneliximab Vapaliximab
Humanized	Immunosuppressive: Apolizumab^§ Aselizumab Atezolizumab Benralizumab Camrelizumab^† Cedelizumab Certolizumab pegol Crizanlizumab Daclizumab Eculizumab Efalizumab^‡ Epratuzumab Erlizumab Etrolizumab^† Fontolizumab Frexalimab^† Inebilizumab Itolizumab Lampalizumab^† Letolizumab Ligelizumab^† Lulizumab pegol Mepolizumab Mogamulizumab Natalizumab Ocrelizumab (+hyaluronidase) Omalizumab Ozoralizumab Pascolizumab Pateclizumab Pembrolizumab Pexelizumab Pidilizumab Plozalizumab PRO 140^† Quilizumab Ravulizumab Reslizumab Retifanlimab Rontalizumab Rovelizumab Ruplizumab Samalizumab Satralizumab Siplizumab Spartalizumab^† Talizumab Teclistamab Teplizumab Tislelizumab Tocilizumab Toralizumab Tregalizumab Vatelizumab Vedolizumab Visilizumab Vobarilizumab TGN1412^§ Immune activation: Dostarlimab Other: Ibalizumab
Chimeric + humanized	Otelixizumab Rozanolixizumab Sutimlimab

Interleukin

Human	Bermekimab Brazikumab Briakinumab Canakinumab Fezakinumab Fletikumab Guselkumab Secukinumab Sirukumab Tralokinumab Ustekinumab
Humanized	Anrukinzumab Bimekizumab Clazakizumab Gevokizumab Ixekizumab Mirikizumab^† Lebrikizumab Olokizumab^† Perakizumab Risankizumab Spesolimab Tildrakizumab
Veterinary	Lokivetmab

Inflammatory lesions

Mouse	Besilesomab Fanolesomab^‡ Lemalesomab Sulesomab

^#WHO-EM
^‡Withdrawn from market
Clinical trials:
- ^†Phase III
- ^§Never to phase III

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