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Odronextamab (REGN1979) is a CD20 x CD3 bispecific monoclonal antibody that is developed by Regeneron Pharmaceuticals for B-cell non-Hodgkin lymphoma.[1][2][3][4]

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.[5] The applicant for this medicinal product is Regeneron Ireland Designated Activity Company.[5]

Names

Odronextamab is the international nonproprietary name.[6]

References

  1. ^ Wei, Joyce; Montalvo-Ortiz, Welby; Yu, Lola; Krasco, Amanda; Olson, Kara; Rizvi, Sahar; et al. (9 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.
  2. ^ Bannerji, Rajat; Arnason, Jon E; Advani, Ranjana H; Brown, Jennifer R; Allan, John N; Ansell, Stephen 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.
  3. ^ Bannerji, Rajat; Allan, John N.; Arnason, Jon E.; Brown, Jennifer R.; Advani, Ranjana; Ansell, Stephen M.; et al. (5 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.
  4. ^ Kim, Tae Min; Alonso, Arancha; Prince, Miles; Taszner, Michal; Cho, Seok-Goo; Stevens, Don A.; et al. (5 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.
  5. ^ a b "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.
  6. ^ World Health Organization (2020). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 83". WHO Drug Information. 34 (1). hdl:10665/339768.


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