Odronextamab
{{Short description|Monoclonal antibody}}
{{Use dmy dates|date=June 2024}}
{{cs1 config |display-authors=6}}
{{Infobox drug
| type = mab
| image =
| alt =
| caption =
| mab_type = BiTE
| source = zu
| pronounce =
| tradename = Ordspono
| Drugs.com =
| MedlinePlus =
| pregnancy_AU =
| pregnancy_AU_comment =
| pregnancy_category=
| routes_of_administration =
| class = Antineoplastic
| ATC_prefix = L01
| ATC_suffix = FX34
| legal_AU =
| legal_AU_comment =
| legal_BR =
| legal_BR_comment =
| legal_CA =
| legal_CA_comment =
| legal_DE =
| legal_DE_comment =
| legal_NZ =
| legal_NZ_comment =
| legal_UK =
| legal_UK_comment =
| legal_US =
| legal_US_comment =
| legal_EU = Rx-only
| legal_EU_comment = {{cite web | title=Ordspono Product information | website=Union Register of medicinal products | date=23 August 2024 | url=https://ec.europa.eu/health/documents/community-register/html/h1843.htm | access-date=27 August 2024}}
| legal_UN =
| legal_UN_comment =
| legal_status =
| bioavailability =
| protein_bound =
| metabolism =
| metabolites =
| onset =
| elimination_half-life =
| duration_of_action=
| excretion =
| CAS_number = 1801338-64-6
| CAS_supplemental =
| PubChem =
| IUPHAR_ligand =
| DrugBank = DB16684
| ChemSpiderID =
| UNII = 8R5CM46UIO
| KEGG = D11534
| ChEBI =
| ChEMBL =
| NIAID_ChemDB =
| PDB_ligand =
| synonyms = REGN1979; REGN-1979
| IUPAC_name =
| C = 6458 | H = 9950 | N = 1728 | O = 2020 | S = 46
}}
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
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.{{cite web | title=Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 June 2024 | website=European Medicines Agency | date=28 June 2024 | url=https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-24-27-june-2024 | access-date=12 July 2024 | archive-date=12 July 2024 | archive-url=https://web.archive.org/web/20240712152232/https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-24-27-june-2024 | url-status=live }} The applicant for this medicinal product is Regeneron Ireland Designated Activity Company.{{cite web | title=Ordspono EPAR | website=European Medicines Agency (EMA) | date=27 June 2024 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/ordspono | access-date=29 June 2024}} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. Odronextamab was approved for medical use in the European Union in August 2024.{{cite press release | title=Ordspono (odronextamab) Approved in the European Union for the Treatment of Relapsed/Refractory Follicular Lymphoma and Diffuse Large B-cell Lymphoma | publisher=Regeneron Pharmaceuticals | via=GlobeNewswire | date=26 August 2024 | url=https://www.globenewswire.com/news-release/2024/08/26/2935368/0/en/Ordspono-odronextamab-Approved-in-the-European-Union-for-the-Treatment-of-Relapsed-Refractory-Follicular-Lymphoma-and-Diffuse-Large-B-cell-Lymphoma.html | access-date=27 August 2024}}
= Names =
Odronextamab is the international nonproprietary name.{{cite journal | vauthors = ((World Health Organization)) | year = 2020 | title = International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 83 | journal = WHO Drug Information | volume = 34 | issue = 1 | hdl = 10665/339768 | hdl-access = free | author-link = World Health Organization }}
References
{{reflist}}
Further reading
- {{cite journal |last1=Bannerji |first1=Rajat |last2=Allan |first2=John N. |last3=Arnason |first3=Jon E. |last4=Brown |first4=Jennifer R. |last5=Advani |first5=Ranjana |last6=Ansell |first6=Stephen M. |last7=O'Brien |first7=Susan M. |last8=Duell |first8=Johannes |last9=Martin |first9=Peter |last10=Joyce |first10=Robin M. |last11=Li |first11=Jingjin |last12=Flink |first12=Dina M. |last13=Zhu |first13=Min |last14=Weinreich |first14=David M. |last15=Yancopoulos |first15=George D. |last16=Sirulnik |first16=Andres |last17=Chaudhry |first17=Aafia |last18=Ambati |first18=Srikanth R. |last19=Topp |first19=Max S. |title=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 |journal=Blood |date=November 2020 |volume=136 |issue=Supplement 1 |pages=42–43 |doi=10.1182/blood-2020-136659|s2cid=228809346 |doi-access=free }}
- {{cite journal |last1=Bannerji |first1=Rajat |last2=Arnason |first2=Jon E |last3=Advani |first3=Ranjana H |last4=Brown |first4=Jennifer R |last5=Allan |first5=John N |last6=Ansell |first6=S tephen M |last7=Barnes |first7=Jeffrey A |last8=O'Brien |first8=Susan M |last9=Chávez |first9=Julio C |last10=Duell |first10=Johannes |last11=Rosenwald |first11=Andreas |last12=Crombie |first12=Jennifer L |last13=Ufkin |first13=Melanie |last14=Li |first14=Jingjin |last15=Zhu |first15=Min |last16=Ambati |first16=Srikanth R |last17=Chaudhry |first17=Aafia |last18=Lowy |first18=Israel |last19=Topp |first19=Max S |title=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 |journal=The Lancet Haematology |date=May 2022 |volume=9 |issue=5 |pages=e327–e339 |doi=10.1016/S2352-3026(22)00072-2|pmid=35366963 |pmc=10681157 }}
- {{cite journal |last1=Kim |first1=Tae Min |last2=Alonso |first2=Arancha |last3=Prince |first3=Miles |last4=Taszner |first4=Michal |last5=Cho |first5=Seok-Goo |last6=Stevens |first6=Don A. |last7=Poon |first7=Michelle |last8=Lim |first8=Francesca |last9=Le Gouill |first9=Steven |last10=Carpio |first10=Cecilia |last11=Keating |first11=Mary-Margaret |last12=Adriaens |first12=Lieve |last13=Ufkin |first13=Melanie |last14=Sabir |first14=Ayesha |last15=Li |first15=Jingjin |last16=Jankovic |first16=Vladimir |last17=Zhu |first17=Min |last18=Brouwer-Visser |first18=Jurriaan |last19=Leng |first19=Siyang |last20=Sirulnik |first20=L. Andres |last21=Chaudhry |first21=Aafia |last22=Ambati |first22=Srikanth R. |last23=Won Seog |first23=Kim |title=A Phase 2 Study of Odronextamab (REGN1979), a CD20 x CD3 Bispecific Antibody, in Patients with Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma |journal=Blood |date=November 2020 |volume=136 |issue=Supplement 1 |pages=28–29 |doi=10.1182/blood-2020-136344|s2cid=228841832 |doi-access=free }}
- {{cite journal |last1=Wei |first1=Joyce |last2=Montalvo-Ortiz |first2=Welby |last3=Yu |first3=Lola |last4=Krasco |first4=Amanda |last5=Olson |first5=Kara |last6=Rizvi |first6=Sahar |last7=Fiaschi |first7=Nathalie |last8=Coetzee |first8=Sandra |last9=Wang |first9=Fang |last10=Ullman |first10=Erica |last11=Ahmed |first11=Hassan Shakil |last12=Herlihy |first12=Evan |last13=Lee |first13=Ken |last14=Havel |first14=Lauren |last15=Potocky |first15=Terra |last16=Ebstein |first16=Sarah |last17=Frleta |first17=Davor |last18=Khatri |first18=Aditi |last19=Godin |first19=Stephen |last20=Hamon |first20=Sara |last21=Brouwer-Visser |first21=Jurriaan |last22=Gorenc |first22=Travis |last23=MacDonald |first23=Doug |last24=Hermann |first24=Aynur |last25=Chaudhry |first25=Aafia |last26=Sirulnik |first26=Andres |last27=Olson |first27=William |last28=Lin |first28=John |last29=Thurston |first29=Gavin |last30=Lowy |first30=Israel |last31=Murphy |first31=Andrew J. |last32=Smith |first32=Eric |last33=Jankovic |first33=Vladimir |last34=Sleeman |first34=Matthew A. |last35=Skokos |first35=Dimitris |title=CD22-targeted CD28 bispecific antibody enhances antitumor efficacy of odronextamab in refractory diffuse large B cell lymphoma models |journal=Science Translational Medicine |date=November 2022 |volume=14 |issue=670 |pages=eabn1082 |doi=10.1126/scitranslmed.abn1082|pmid=36350988 |s2cid=253445866 }}
{{Targeted cancer therapeutic agents}}
{{Monoclonals for tumors}}
{{Portal bar | Medicine}}
{{Authority control}}