Reported Earlier, AbbVie's Epcoritamab Receives EMA Opinion for Follicular Lymphoma Treatment
Reported Earlier, AbbVie's Epcoritamab Receives EMA Opinion for Follicular Lymphoma Treatment
據報道，艾伯維公司的Epcoritamab獲得歐洲藥品管理局對濾泡性淋巴瘤治療的意見
AbbVie (NYSE:ABBV) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the conditional marketing authorization of epcoritamab (TEPKINLY), the first and only T-cell engaging bispecific antibody administered subcutaneously (under the skin), as a monotherapy for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more prior therapies. The European Commission decision on this indication for epcoritamab is anticipated later this year.
AbbVie（紐交所：ABBV）今天宣佈，歐洲藥品管理局（EMA）人用藥品委員會（CHMP）已經採納了積極建議，推薦條件性上市授權epcoritamab（TEPKINLY），這是第一個也是唯一一個皮下注射的T細胞結合雙特異性抗體，單藥治療成人復發或難治性毛細胞淋巴瘤（FL），在至少兩種先前治療失敗後。預計歐洲委員會將於今年晚些時候就這種適應症作出決定。
"Patients with follicular lymphoma are likely to face disease recurrence and shorter durability of response...
艾伯維公司血液學治療領域治療區...
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