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2024-07-01T13:20:34.000Z

Odronextamab receives positive CHMP opinion for the treatment of adult patients with R/R FL and R/R DLBCL

Jul 1, 2024
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Learning objective: After reading this article, learners will be able to cite a new clinical development in lymphoma.

On June 28, 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending approval of odronextamab, a CD20xCD3 bispecific antibody, for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL), who progress after ≥2 lines of systemic therapy. This announcement is based on key results from the phase I ELM-1 (NCT02290951) and phase II ELM-2 (NCT03888105) clinical trials, which demonstrated robust, durable response rates and an acceptable safety profile of odronextamab in adults with R/R FL or R/R DLBCL. The most common serious adverse reactions included cytokine release syndrome, pneumonia, COVID-19, and pyrexia.

  1. Globe Newswire. Odronextamab recommended for EU Approval by the CHMP to treat relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma. https://www.globenewswire.com/news-release/2024/06/28/2905764/0/en/Odronextamab-Recommended-for-EU-Approval-by-the-CHMP-to-Treat-Relapsed-Refractory-Follicular-Lymphoma-and-Diffuse-Large-B-cell-Lymphoma.html. Published Jun 28, 2024. Accessed Jul 1, 2024.

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