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歐盟獲得批准作爲單一治療藥物用於治療復發或難治性濾泡性淋巴瘤（FL）和復發或難治性瀰漫性大B細胞淋巴瘤（DLBCL）的皮下雙特異性抗體，經過兩種或兩種以上系統治療後。
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.
丹麥哥本哈根，2024年8月19日 - Genmab A / S（納斯達克：genmab）今天宣佈，歐洲委員會（EC）已授予TEPKINLY（epcoritamab）有條件的上市授權，作爲單一治療成人患者的治療難治性濾泡性淋巴瘤（FL）的復發或難治性（R / R）在經過兩種或兩種以上的系統治療後。TEPKINLY是歐盟以及歐洲經濟區（Iceland、Liechtenstein、Norway）和北愛爾蘭治療這種患者群體的第一款和唯一的皮下T細胞結合的雙特異性抗體。
