Odronextamab

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	L01FX34 ( WHO )
Legal status
Legal status	EU:Rx-only [1] [2]
Identifiers
CAS Number	1801338-64-6
DrugBank	DB16684
UNII	8R5CM46UIO
KEGG	D11534
Chemical and physical data
Formula	C6458H9950N1728O2020S46
Molar mass	145593.47 g·mol−1

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. "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.
2. "Ordspono Product information". Union Register of medicinal products. 23 August 2024. Retrieved 27 August 2024.
3. "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.
4. "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.
5. World Health Organization (2020). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 83". WHO Drug Information. 34 (1). hdl: 10665/339768 .

Further reading

• 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.