Odronextamab - Misplaced Pages

Monoclonal antibody

Pharmaceutical compound

Odronextamab
Monoclonal antibody
Type	Bi-specific T-cell engager
Source	Humanized
Target	CD20, CD3
Clinical data
Trade names	Ordspono
Other names	REGN1979; REGN-1979
Drug class	Antineoplastic
ATC code	None
Legal status
Legal status	EU: Rx-only
Identifiers
CAS Number	1801338-64-6
DrugBank	DB16684
UNII	8R5CM46UIO
KEGG	D11534
Chemical and physical data
Formula	C₆₄₅₈H₉₉₅₀N₁₇₂₈O₂₀₂₀S₄₆
Molar mass	145593.47 g·mol

Odronextamab, sold under the brand name Ordspono, is a CD20 x CD3 bispecific monoclonal antibody that is used for the treatment of follicular lymphoma or diffuse large B-cell lymphoma. It was developed by Regeneron Pharmaceuticals.

The most common side effects include cytokine release syndrome, infections, neutropenia, pyrexia (fever), anemia, thrombocytopenia, and diarrhea.

Odronextamab was approved for medical use in the European Union in August 2024.

Medical uses

Odronextamab is indicated for the treatment of adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy; and for the treatment of adults with relapsed or refractory diffuse large B‑cell lymphoma after two or more lines of systemic therapy.

Side Effects

The most common side effects include cytokine release syndrome, infections, neutropenia, pyrexia, anemia, thrombocytopenia, and diarrhea.

Society and culture

Legal status

In June 2024, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a conditional marketing authorization for the medicinal product Ordspono, intended for the treatment of follicular lymphoma and diffuse large B-cell lymphoma. The applicant for this medicinal product is Regeneron Ireland Designated Activity Company. Odronextamab was approved for medical use in the European Union in August 2024.

Names

Odronextamab is the international nonproprietary name.

References

^ "Ordspono EPAR". European Medicines Agency (EMA). 27 June 2024. Retrieved 29 June 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
^ "Ordspono Product information". Union Register of medicinal products. 23 August 2024. Retrieved 27 August 2024.
"Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 June 2024". European Medicines Agency. 28 June 2024. Archived from the original on 12 July 2024. Retrieved 12 July 2024.
"Ordspono (odronextamab) Approved in the European Union for the Treatment of Relapsed/Refractory Follicular Lymphoma and Diffuse Large B-cell Lymphoma" (Press release). Regeneron Pharmaceuticals. 26 August 2024. Retrieved 27 August 2024 – via GlobeNewswire.
World Health Organization (2020). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 83". WHO Drug Information. 34 (1). hdl:10665/339768.

Bannerji, Rajat; Allan, John N.; Arnason, Jon E.; Brown, Jennifer R.; Advani, Ranjana; Ansell, Stephen M.; et al. (November 2020). "Odronextamab (REGN1979), a Human CD20 x CD3 Bispecific Antibody, Induces Durable, Complete Responses in Patients with Highly Refractory B-Cell Non-Hodgkin Lymphoma, Including Patients Refractory to CAR T Therapy". Blood. 136 (Supplement 1): 42–43. doi:10.1182/blood-2020-136659. S2CID 228809346.
Bannerji, Rajat; Arnason, Jon E; Advani, Ranjana H; Brown, Jennifer R; Allan, John N; Ansell, S tephen M; et al. (May 2022). "Odronextamab, a human CD20×CD3 bispecific antibody in patients with CD20-positive B-cell malignancies (ELM-1): results from the relapsed or refractory non-Hodgkin lymphoma cohort in a single-arm, multicentre, phase 1 trial". The Lancet Haematology. 9 (5): e327–e339. doi:10.1016/S2352-3026(22)00072-2. PMC 10681157. PMID 35366963.
Kim, Tae Min; Alonso, Arancha; Prince, Miles; Taszner, Michal; Cho, Seok-Goo; Stevens, Don A.; et al. (November 2020). "A Phase 2 Study of Odronextamab (REGN1979), a CD20 x CD3 Bispecific Antibody, in Patients with Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma". Blood. 136 (Supplement 1): 28–29. doi:10.1182/blood-2020-136344. S2CID 228841832.
Wei, Joyce; Montalvo-Ortiz, Welby; Yu, Lola; Krasco, Amanda; Olson, Kara; Rizvi, Sahar; et al. (November 2022). "CD22-targeted CD28 bispecific antibody enhances antitumor efficacy of odronextamab in refractory diffuse large B cell lymphoma models". Science Translational Medicine. 14 (670): eabn1082. doi:10.1126/scitranslmed.abn1082. PMID 36350988. S2CID 253445866.

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 Cosibelimab 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 Zenocutuzumab 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

Monoclonal antibodies for tumors

Tumor

Human	Adecatumumab Amivantamab Ascrinvacumab Atezolizumab (+hyaluronidase) Balstilimab Botensilimab Cixutumumab Conatumumab Cosibelimab 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 Zenocutuzumab
Rat/mouse hybrid	Catumaxomab Ertumaxomab
Chimeric + humanized	Depatuxizumab mafodotin Duvortuxizumab Ontuxizumab

WHO-EM
Withdrawn from market
Clinical trials:
- Phase III
- Never to phase III

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