{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,10]],"date-time":"2026-09-10T05:11:35Z","timestamp":1789017095571,"version":"build-2803163510"},"reference-count":25,"publisher":"Springer Science and Business Media LLC","issue":"12","license":[{"start":{"date-parts":[[2024,11,19]],"date-time":"2024-11-19T00:00:00Z","timestamp":1731974400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"},{"start":{"date-parts":[[2024,11,19]],"date-time":"2024-11-19T00:00:00Z","timestamp":1731974400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Drugs"],"published-print":{"date-parts":[[2024,12]]},"DOI":"10.1007\/s40265-024-02112-6","type":"journal-article","created":{"date-parts":[[2024,11,18]],"date-time":"2024-11-18T22:57:17Z","timestamp":1731970637000},"page":"1651-1658","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["Odronextamab: First Approval"],"prefix":"10.1007","volume":"84","author":[{"given":"Hannah A.","family":"Blair","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,11,19]]},"reference":[{"issue":"7","key":"2112_CR1","doi-asserted-by":"publisher","first-page":"539","DOI":"10.1038\/s41571-024-00905-y","volume":"21","author":"ME Goebeler","year":"2024","unstructured":"Goebeler ME, Stuhler G, Bargou R. Bispecific and multispecific antibodies in oncology: opportunities and challenges. Nat Rev Clin Oncol. 2024;21(7):539\u201360.","journal-title":"Nat Rev Clin Oncol"},{"key":"2112_CR2","unstructured":"Regeneron Pharmaceuticals. Ordspono\u2122 (odronextamab) approved in the European Union for the treatment of relapsed\/refractory follicular lymphoma and diffuse large B-cell lymphoma [media release]. 26 Aug 2024. https:\/\/investor.regeneron.com\/news-releases\/news-release-details\/ordsponotm-odronextamab-approved-european-union-treatment."},{"key":"2112_CR3","unstructured":"Regeneron Pharmaceuticals. Pivotal odronextamab (CD20xCD3) phase 2 data in patients with relapsed\/refractory diffuse large B-cell lymphoma debut at ASH [media release].11 Dec 2022. http:\/\/www.regeneron.com."},{"key":"2112_CR4","unstructured":"Regeneron Pharmaceuticals. Regeneron provides update on Biologics License Application for odronextamab [media release]. 25 Mar 2024. http:\/\/www.regeneron.com."},{"key":"2112_CR5","unstructured":"European Medicines Agency. Ordspono (odronextamab) concentrate for solution for infusion: EU summary of product characteristics. 2024. https:\/\/ec.europa.eu\/health\/documents\/community-register\/2024\/20240822163419\/anx_163419_en.pdf. Accessed 10 Oct 2024."},{"key":"2112_CR6","unstructured":"Regeneron Pharmaceuticals. Regeneron reports second quarter 2017 financial and operating results [media release]. 3 Aug 2017. http:\/\/www.regeneron.com."},{"key":"2112_CR7","unstructured":"U.S. Food & Drug Administration. US FDA orphan drug designation\u2014odronextamab (REGN1979). 2020. https:\/\/www.accessdata.fda.gov\/scripts\/opdlisting\/oopd\/detailedIndex.cfm?cfgridkey=623317. Accessed 10 Oct 2024."},{"key":"2112_CR8","unstructured":"Regeneron Pharmaceuticals. Regeneron reports first quarter 2022 financial and operating results [media release]. 4 May 2022. http:\/\/www.regeneron.com."},{"key":"2112_CR9","unstructured":"Regeneron Pharmaceuticals. Regeneron and Zai Lab announce regional strategic collaboration for REGN1979 (CD20xCD3 bispecific antibody) [media release]. 8 Apr 2020. http:\/\/www.regeneron.com."},{"key":"2112_CR10","unstructured":"United States Securities and Exchange Commission. Zai Lab Limited. Form 10-K. 2023. https:\/\/www.sec.gov\/ix?doc=\/Archives\/edgar\/data\/1704292\/000162828024007235\/zlab-20231231.htm. Accessed 10 Oct 2024."},{"key":"2112_CR11","unstructured":"United States Securities and Exchange Commission. Zai Lab Limited. Form 10-K. 2021. https:\/\/www.sec.gov\/ix?doc=\/Archives\/edgar\/data\/1704292\/000119312522061312\/d261426d10k.htm. Accessed 10 Oct 2024."},{"issue":"4","key":"2112_CR12","doi-asserted-by":"publisher","first-page":"954","DOI":"10.1111\/cts.13212","volume":"15","author":"M Zhu","year":"2022","unstructured":"Zhu M, Olson K, Kirshner JR, et al. Translational findings for odronextamab: from preclinical research to a first-in-human study in patients with CD20+ B-cell malignancies. Clin Transl Sci. 2022;15(4):954\u201366.","journal-title":"Clin Transl Sci"},{"key":"2112_CR13","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1038\/srep17943","volume":"5","author":"EJ Smith","year":"2015","unstructured":"Smith EJ, Olson K, Haber LJ, et al. A novel, native-format bispecific antibody triggering T-cell killing of B-cells is robustly active in mouse tumor models and cynomolgus monkeys. Sci Rep. 2015;5:1\u201312.","journal-title":"Sci Rep"},{"issue":"5","key":"2112_CR14","doi-asserted-by":"publisher","first-page":"e327","DOI":"10.1016\/S2352-3026(22)00072-2","volume":"9","author":"R Bannerji","year":"2022","unstructured":"Bannerji R, Arnason JE, Advani RH, et al. Odronextamab, a human CD20\u00d7CD3 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. Lancet Haematol. 2022;9(5):e327\u201339.","journal-title":"Lancet Haematol."},{"issue":"S1","key":"2112_CR15","first-page":"2128","volume":"8","author":"M Matasar","year":"2024","unstructured":"Matasar M, Crombie J, Topp M, et al. Odronextamab demonstrates durable complete responses in patients with diffuse large B-cell lymphoma (DLBCL) progressing after CAR-T therapy: outcomes from the ELM-1 study [abstract no. P1162]. HemaSphere. 2024;8(S1):2128\u20139.","journal-title":"HemaSphere"},{"key":"2112_CR16","doi-asserted-by":"publisher","DOI":"10.1016\/j.annonc.2024.08.2239","author":"TM Kim","year":"2024","unstructured":"Kim TM, Taszner M, Novelli S, et al. Safety and efficacy of odronextamab in patients with relapsed or refractory follicular lymphoma. Ann Oncol. 2024. https:\/\/doi.org\/10.1016\/j.annonc.2024.08.2239.","journal-title":"Ann Oncol"},{"key":"2112_CR17","doi-asserted-by":"crossref","unstructured":"Ayyappan S, Kim WS, Kim TM, et al. Final analysis of the phase II ELM-2 study: odronextamab in patients with relapsed\/refractory (R\/R) diffuse large B-cell lymphoma (DLBCL) [abstract no. 436 + oral presentation]. In: American Society of Hematology (ASH) annual meeting and exposition. 2023.","DOI":"10.1182\/blood-2023-179818"},{"issue":"Suppl. 1","key":"2112_CR18","doi-asserted-by":"publisher","first-page":"4504","DOI":"10.1182\/blood-2023-180743","volume":"142","author":"E Iskierka-Jazdzewska","year":"2023","unstructured":"Iskierka-Jazdzewska E, Kim WS, Cho SG, et al. Health-related quality of life and symptoms in patients with relapsed or refractory diffuse large B-cell lymphoma treated with odronextamab monotherapy in the phase 2 ELM-2 study [abstract no. 627 plus poster 4504]. Blood. 2023;142(Suppl. 1):4504\u20136.","journal-title":"Blood"},{"issue":"Suppl. 1","key":"2112_CR19","doi-asserted-by":"publisher","first-page":"669","DOI":"10.1182\/blood-2023-181942","volume":"142","author":"B Tessoulin","year":"2023","unstructured":"Tessoulin B, Cho SG, Taszner M, et al. Maintenance of moderate to high levels of functioning and quality of life with odronextamab monotherapy in patients with relapsed or refractory follicular lymphoma [abstract no. 905]. Blood. 2023;142(Suppl. 1):669\u201372.","journal-title":"Blood"},{"key":"2112_CR20","unstructured":"US National Institutes of Health. ClinicalTrials identifier NCT03888105. 2021. https:\/\/clinicaltrials.gov. Accessed 10 Oct 2024."},{"key":"2112_CR21","doi-asserted-by":"crossref","unstructured":"Birhiray RE, Luminari S, Kim TM, et al. Phase 3 trial evaluating the efficacy and safety of odronextamab versus investigator\u2019s choice in previously untreated follicular lymphoma (OLYMPIA-1) [abstract no. TPS7096]. J Clin Oncol. 2024;42(16_Suppl.).","DOI":"10.1200\/JCO.2024.42.16_suppl.TPS7096"},{"key":"2112_CR22","doi-asserted-by":"crossref","unstructured":"Hardin C, Gray C, Novelli S, et al. Phase 3 trial evaluating the efficacy and safety of odronextamab plus chemotherapy versus rituximab plus chemotherapy in previously untreated follicular lymphoma (OLYMPIA-2) [abstract no. TPS7099]. J Clin Oncol. 2024;42(16_Suppl.).","DOI":"10.1200\/JCO.2024.42.16_suppl.TPS7099"},{"key":"2112_CR23","doi-asserted-by":"crossref","unstructured":"Vitolo U, Merli M, Norasetthada L, et al. Phase 3 trial of odronextamab plus lenalidomide versus rituximab plus lenalidomide in relapsed\/refractory (R\/R) follicular lymphoma (FL) and marginal zone lymphoma (MZL; OLYMPIA-5) [abstract no. TPS7094]. J Clin Oncol. 2024;42(16_Suppl.).","DOI":"10.1200\/JCO.2024.42.16_suppl.TPS7094"},{"key":"2112_CR24","doi-asserted-by":"crossref","unstructured":"Matasar M, Turgut B, Tessoulin B, et al. Phase 3 trial evaluating efficacy and safety of odronextamab plus CHOP vs rituximab plus CHOP in previously untreated diffuse large B-cell lymphoma (DLBCL; OLYMPIA-3) [abstract no. TPS7086]. J Clin Oncol. 2024;42(16_Suppl.).","DOI":"10.1200\/JCO.2024.42.16_suppl.TPS7086"},{"key":"2112_CR25","doi-asserted-by":"crossref","unstructured":"Hawkes EA, Kim TM, Donato Martin EM, et al. Phase 3 trial evaluating the efficacy and safety of odronextamab versus standard-of-care (SOC) therapy in relapsed\/refractory (R\/R) aggressive B-cell non-Hodgkin lymphoma (B-NHL; OLYMPIA-4) [abstract no. TPS7093]. J Clin Oncol. 2024;42(16_Suppl.).","DOI":"10.1200\/JCO.2024.42.16_suppl.TPS7093"}],"container-title":["Drugs"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40265-024-02112-6.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s40265-024-02112-6\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40265-024-02112-6.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,12,17]],"date-time":"2024-12-17T21:14:00Z","timestamp":1734470040000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s40265-024-02112-6"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,11,19]]},"references-count":25,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2024,12]]}},"alternative-id":["2112"],"URL":"https:\/\/doi.org\/10.1007\/s40265-024-02112-6","relation":{},"ISSN":["0012-6667","1179-1950"],"issn-type":[{"value":"0012-6667","type":"print"},{"value":"1179-1950","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,11,19]]},"assertion":[{"value":"13 October 2024","order":1,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"19 November 2024","order":2,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The preparation of this review was not supported by any external funding.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"During the peer review process, the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Hannah A. Blair is a salaried employee of Adis International Ltd\/Springer Nature and declares no relevant conflicts of interest. All authors contributed to this article and are responsible for its content.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Authorship and Conflict of interest"}},{"value":"Not applicable.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability"}}]}}