Chemistry:Odronextamab
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.[1][2] It was developed by Regeneron Pharmaceuticals.[1]
The most common side effects include cytokine release syndrome, infections, neutropenia, pyrexia (fever), anemia, thrombocytopenia, and diarrhea.[1]
Odronextamab was approved for medical use in the European Union in August 2024.[1][2]
Medical uses
Odronextamab is indicated for the treatment of adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy;[1] and for the treatment of adults with relapsed or refractory diffuse large B‑cell lymphoma after two or more lines of systemic therapy.[1]
Side Effects
The most common side effects include cytokine release syndrome, infections, neutropenia, pyrexia, anemia, thrombocytopenia, and diarrhea.[1]
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.[1][3] The applicant for this medicinal product is Regeneron Ireland Designated Activity Company.[1] Odronextamab was approved for medical use in the European Union in August 2024.[1][2][4]
Names
Odronextamab is the international nonproprietary name.[5]
References
- ↑ 1.00 1.01 1.02 1.03 1.04 1.05 1.06 1.07 1.08 1.09 "Ordspono EPAR". 27 June 2024. https://www.ema.europa.eu/en/medicines/human/EPAR/ordspono. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ↑ 2.0 2.1 2.2 Cite error: Invalid
<ref>tag; no text was provided for refs namedOrdspono PI - ↑ "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 June 2024". 28 June 2024. https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-24-27-june-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.
- ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 83". WHO Drug Information 34 (1). 2020.
Further reading
- Bannerji, Rajat; Allan, John N.; Arnason, Jon E.; Brown, Jennifer R.; Advani, Ranjana; Ansell, Stephen M.; O'Brien, Susan M.; Duell, Johannes 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.
- Bannerji, Rajat; Arnason, Jon E; Advani, Ranjana H; Brown, Jennifer R; Allan, John N; Ansell, S tephen M; Barnes, Jeffrey A; O'Brien, Susan 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. PMID 35366963.
- Kim, Tae Min; Alonso, Arancha; Prince, Miles; Taszner, Michal; Cho, Seok-Goo; Stevens, Don A.; Poon, Michelle; Lim, Francesca 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.
- Wei, Joyce; Montalvo-Ortiz, Welby; Yu, Lola; Krasco, Amanda; Olson, Kara; Rizvi, Sahar; Fiaschi, Nathalie; Coetzee, Sandra 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). doi:10.1126/scitranslmed.abn1082. PMID 36350988.
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