Reported Earlier, FDA Approves Amgen's IMDELLTRA (Tarlatamab-dlle) The First And Only T-Cell Engager Therapy For The Treatment Of Extensive-Stage Small Cell Lung Cancer
Reported Earlier, FDA Approves Amgen's IMDELLTRA (Tarlatamab-dlle) The First And Only T-Cell Engager Therapy For The Treatment Of Extensive-Stage Small Cell Lung Cancer
Breakthrough DLL3-Targeting Therapy Regimen for a Major Solid Tumor
针对主要实体瘤的突破性 DLL3 靶向治疗方案
IMDELLTRA Demonstrated Impressive 40% Objective Response Rate, 9.7 Month Median Duration of Response and 14.3 Month Median Overall Survival in Pivotal DeLLphi-301 Study
IMDELLTRA在关键的DellPHI-301研究中显示出令人印象深刻的40％的客观反应率、9.7个月的中位缓解时间和14.3个月的总存活率中位数
Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved IMDELLTRA (tarlatamab-dlle) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. IMDELLTRA has received accelerated approval based on the encouraging response rate and duration of response (DoR) observed in clinical studies. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
安进（纳斯达克股票代码：AMGN）今天宣布，美国食品药品监督管理局（FDA）已批准IMDELLTRA（tarlatamab-dlle）用于治疗在铂类化疗期间或之后出现疾病进展的广泛期小细胞肺癌（ES-SCLC）的成年患者。基于临床研究中观察到的令人鼓舞的回复率和缓解持续时间（DoR），IMDELLTRA获得了加速批准。该适应症的持续批准可能取决于确认性试验中对临床益处的验证和描述。