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.
再生元製藥公司（納斯達克股票代碼：REGN）今天宣佈，歐洲藥品管理局（EMA）人用藥品委員會（CHMP）已採納了一項積極意見，建議有條件地批准odronextamab用於治療成年復發/難治性濾泡性淋巴瘤（FL）或復發/難治性瀰漫大B細胞淋巴瘤（DLBCL）患者，在兩種或兩種以上的全身治療方案後。歐洲委員會有望在未來幾個月宣佈最終決定。
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細胞非霍奇金淋巴瘤（B-NHL）的兩種最常見亞型。雖然FL是一種慢性亞型，但它是一種不可治癒的疾病，大多數患者會在初始治療後復發。DLBCL是一種侵襲性亞型，高風險患者中有高達50%在一線治療後（例如，復發或難治）會出現進展。全球每年約有120,000例FL病例和163,000例DLBCL病例。在歐洲，每年約有15,000例FL病例和31,000例DLBCL病例被診斷。
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.
積極的CHMP意見得到了1期ELM-1和關鍵性2期ELM-2試驗的結果支持，該試驗證明了odronextamab在成人復發/難治性FL或DLBCL中具有穩健、持久的反應率和良好的安全性。在一個彙總的安全人群中，最常見的嚴重不良反應是細胞因子釋放綜合徵、肺炎、 COVID-19和發熱。
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先前爲FL和DLBCL均授予了odronextamab孤兒藥認定。odronextamab目前正在進行臨床開發，並尚未獲得任何監管機構的批准。
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.
再生元繼續評估odronextamab在難治性淋巴瘤中作爲單藥和聯合早期治療方案的使用。這包括註冊ELM-1和ELM-2研究，第3期OLYMPIA發展計劃，該計劃是淋巴瘤中最大的臨床計劃之一，評估odronextamab在早期治療和其他B-NHL中的化療無關聯合的早期試驗。