Regeneron's Odronextamab Receives Opinion From EMA for Lymphoma Treatment
Regeneron's Odronextamab Receives Opinion From EMA for Lymphoma Treatment
Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending conditional marketing authorization of odronextamab to treat adults with relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy. The European Commission is expected to announce a final decision in the coming months.
再生元制药公司（纳斯达克股票代码：REGN）今天宣布，欧洲药品管理局（EMA）人用药品委员会（CHMP）已采纳了一项积极意见，建议有条件地批准odronextamab用于治疗成年复发/难治性滤泡性淋巴瘤（FL）或复发/难治性弥漫大B细胞淋巴瘤（DLBCL）患者，在两种或两种以上的全身治疗方案后。欧洲委员会有望在未来几个月宣布最终决定。
FL and DLBCL are the two most common subtypes of B-cell non-Hodgkin lymphoma (B-NHL). While FL is a slow-growing subtype, it is an incurable disease, and most patients will relapse after initial treatment. DLBCL is an aggressive subtype, with up to 50% of high-risk patients experiencing progression after first-line treatment (e.g., relapsing or refractory to treatment). It is estimated that approximately 120,000 FL cases and 163,000 DLBCL cases are diagnosed annually worldwide. In Europe, it is estimated that approximately 15,000 FL cases and 31,000 DLBCL cases are diagnosed each year.
FL和DLBCL是B细胞非霍奇金淋巴瘤（B-NHL）的两种最常见亚型。虽然FL是一种慢性亚型，但它是一种不可治愈的疾病，大多数患者会在初始治疗后复发。DLBCL是一种侵袭性亚型，高风险患者中有高达50%在一线治疗后（例如，复发或难治）会出现进展。全球每年约有120,000例FL病例和163,000例DLBCL病例。在欧洲，每年约有15,000例FL病例和31,000例DLBCL病例被诊断。
The positive CHMP opinion is supported by results from the Phase 1 ELM-1 and pivotal Phase 2 ELM-2 trials, which demonstrated robust, durable response rates and an acceptable safety profile of odronextamab in adults with R/R FL or R/R DLBCL. In a pooled safety population, the most common serious adverse reactions were cytokine release syndrome, pneumonia, COVID-19 and pyrexia.
积极的CHMP意见得到了1期ELM-1和关键性2期ELM-2试验的结果支持，该试验证明了odronextamab在成人复发/难治性FL或DLBCL中具有稳健、持久的反应率和良好的安全性。在一个汇总的安全人群中，最常见的严重不良反应是细胞因子释放综合征、肺炎、 COVID-19和发热。
The EMA previously granted odronextamab Orphan Designation for both FL and DLBCL. Odronextamab is currently under clinical development and has not been approved by any regulatory authority.
EMA先前为FL和DLBCL均授予了odronextamab孤儿药认定。odronextamab目前正在进行临床开发，并尚未获得任何监管机构的批准。
Regeneron continues to evaluate the use of odronextamab as a monotherapy and in combination across earlier lines of therapy in challenging-to-treat lymphomas. This includes the registrational ELM-1 and ELM-2 studies, the Phase 3 OLYMPIA development program, which is one of the largest clinical programs in lymphoma evaluating odronextamab in earlier lines of therapy and additional B-NHLs, as well as early-stage trials with chemotherapy-free combinations.
再生元继续评估odronextamab在难治性淋巴瘤中作为单药和联合早期治疗方案的使用。这包括注册ELM-1和ELM-2研究，第3期OLYMPIA发展计划，该计划是淋巴瘤中最大的临床计划之一，评估odronextamab在早期治疗和其他B-NHL中的化疗无关联合的早期试验。