Genmab A/S Announces TEPKINLY Has Received Second European Commission Approval For The Treatment Of Relapsed/Refractory Follicular Lymphoma In Adults
Genmab A/S Announces TEPKINLY Has Received Second European Commission Approval For The Treatment Of Relapsed/Refractory Follicular Lymphoma In Adults
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TEPKINLY is the first and only subcutaneous bispecific antibody approved as a monotherapy in the European Union to treat both relapsed or refractory (R/R) follicular lymphoma (FL) and R/R diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy
- TEPKINLY是第一款也是唯一一款在欧盟获得批准作为单一治疗药物用于治疗复发或难治性滤泡性淋巴瘤（FL）和复发或难治性弥漫性大B细胞淋巴瘤（DLBCL）的皮下双特异性抗体，经过两种或两种以上系统治疗后。
COPENHAGEN, Denmark; August 19, 2024 – Genmab A/S (NASDAQ:GMAB) today announced that the European Commission (EC) has granted conditional marketing authorization for TEPKINLY (epcoritamab) as a monotherapy for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. TEPKINLY is the first and only subcutaneous T-cell engaging bispecific antibody approved for the treatment of this patient population in the European Union (EU), as well as the European Economic Area (EEA) countries (Iceland, Liechtenstein, Norway) and Northern Ireland.
丹麦哥本哈根，2024年8月19日 - Genmab A / S（纳斯达克：genmab）今天宣布，欧洲委员会（EC）已授予TEPKINLY（epcoritamab）有条件的上市授权，作为单一治疗成人患者的治疗难治性滤泡性淋巴瘤（FL）的复发或难治性（R / R）在经过两种或两种以上的系统治疗后。TEPKINLY是欧盟以及欧洲经济区（Iceland、Liechtenstein、Norway）和北爱尔兰治疗这种患者群体的第一款和唯一的皮下T细胞结合的双特异性抗体。