FDA Gives Accelerated Approval To Amgen's Drug For Small Cell Lung Cancer Patients
FDA Gives Accelerated Approval To Amgen's Drug For Small Cell Lung Cancer Patients
Thursday, the FDA approved Amgen Inc's (NASDAQ:AMGN) 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.
周四，美国食品药品管理局批准了安进公司（纳斯达克股票代码：AMGN）的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。
Imdelltra has received accelerated approval based on the response rate and duration of response (DoR) observed in clinical studies.
根据临床研究中观察到的回复率和反应持续时间（DoR），Imdelltra已获得加速批准。
Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
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。
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"Less than 3% of patients with ES-SCLC live longer than five years," said David Carbone, professor of internal medicine and director of the James Thoracic Oncology Center at the Ohio State University Medical Center.
俄亥俄州立大学医学中心内科教授兼詹姆斯胸部肿瘤中心主任戴维·卡本说：“不到3％的ES-SCLC患者的寿命超过五年。”
Imdelltra is the first and only DLL3-targeting Bispecific T-cell Engager therapy that activates the patient's T cells to attack DLL3-expressing tumor cells.
Imdelltra是第一种也是唯一一种靶向DLL3的双特异性T细胞Engager疗法，它激活患者的T细胞攻击表达DLL3的肿瘤细胞。
The FDA accelerated approval of Imdelltra is based on results from the Phase 2 DeLLphi-301 clinical trial that evaluated Imdelltra in patients with SCLC who had failed two or more prior lines of treatment, and who had received the 10 mg every two weeks dosing (Q2W) regimen.
美国食品药品管理局加速批准Imdelltra的依据是Dellphi-301第二阶段临床试验的结果，该试验评估了Imdelltra对先前两条或更多线路治疗失败且每两周接受10毫克给药（Q2W）方案的SCLC患者。
The study's results found that Imdelltra at the 10 mg Q2W dose (N=99) demonstrated an objective response rate (ORR) of 40% and a median DoR of 9.7 months.
该研究的结果发现，在10毫克的Q2W剂量（N=99）下，Imdelltra的客观缓解率（ORR）为40％，中位DoR为9.7个月。
The median overall survival (mOS) was 14.3 months, with final and complete survival data yet to mature.
中位总存活率（MoS）为14.3个月，最终和完整的存活数据尚未成熟。
The Imdelltra label includes a Boxed Warning for cytokine release syndrome and neurologic toxicity.
Imdelltra 标签包括关于细胞因子释放综合征和神经系统毒性的盒装警告。
Price Action: AMGN shares traded lower by 0.94% at $311.75 at last check Friday.
价格走势：周五最后一次检查时，AMGN股价下跌0.94％，至311.75美元。
Photo by Minerva Studio via Shutterstock
照片由 Minerva Studio 通过 Shutterstock 拍摄