Merus Scores Its First FDA Approval For Lung Cancer Drug
Merus Scores Its First FDA Approval For Lung Cancer Drug
These indications are approved under accelerated approval based on the overall response rate (ORR) and duration of response (DOR).On Wednesday, the FDA approved Merus N.V.'s (NASDAQ:MRUS) Bizengri (zenocutuzumab-zbco) as the first and only treatment indicated for adults with pancreatic adenocarcinoma or non–small cell lung cancer (NSCLC) that are advanced unresectable or metastatic and harbor a neuregulin 1 (NRG1) gene fusion who have disease progression on or after prior systemic therapy.
在周三，FDA批准了Merus N.V.（纳斯达克：MRUS）的Bizengri（zenocutuzumab-zbco）作为首个也是唯一一个针对晚期不可切除或转移性胰腺腺癌或非小细胞肺癌（NSCLC）成人的治疗，其患者携带神经调节蛋白1（NRG1）基因融合，并在前期系统治疗后病情恶化。
Bizengri is Merus's first approved medicine and is based on the proprietary Biclonics technology platform.
Bizengri是Merus的首个获批药物，基于专有的Biclonics科技平台。
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These indications are approved under accelerated approval based on the overall response rate (ORR) and duration of response (DOR).
这些适应症是基于总体响应率（ORR）和响应持续时间（DOR）获得加速批准的。
Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
对这些适应症的持续批准可能取决于在确认试验中验证和描述临床效益。
Bizengri 20 mg/mL Injection for Intravenous Use is expected to be available to patients in the coming weeks.
Bizengri 20 mg/mL注射液预计将在未来几周内可供患者使用。
Bizengri's approval is based on data from the eNRGy trial. In patients with NRG1+ pancreatic adenocarcinoma (n=30), Bizengri demonstrated an ORR of 40%.
Bizengri的批准基于eNRGy试验的数据。在NRG1+ 胰腺腺癌患者（n=30）中，Bizengri的ORR为40%。
DOR in NRG1+ pancreatic adenocarcinoma ranged from 3.7 months to 16.6 months. In the same trial, patients with NRG1+ NSCLC (n=64) treated with Bizengri demonstrated an ORR of 33%. The median DOR in NRG1+ NSCLC was 7.4 months.
在NRG1+ 胰腺腺癌患者中，DOR范围为3.7个月至16.6个月。在同一试验中，使用Bizengri治疗的NRG1+ NSCLC患者（n=64）显示ORR为33%。NRG1+ NSCLC的中位DOR为7.4个月。
b writes, "Investor focus remains on petosemtamab, with the next key catalyst for the company being updated data for petosemtamab in previously treated head and neck squamous cell carcinoma (HNSCC) at ESMO Asia on December 7."
b 写道：“投资者关注仍然在 petosemtamab 上，公司的下一个关键催化剂将是 12 月 7 日在 ESMO 亚洲会议上更新的 previously treated 头颈部鳞状细胞癌 (HNSCC) 的 petosemtamab 数据。”
The analyst assumes Bizengri will be priced at roughly $30,000 per treatment and estimates combined peak U.S. sales in NRG1 fusion NSCLC and PDAC attributable to Merus (based on an estimated 8% royalty rate) of roughly $16.5 million.
分析师假设 Bizengri 的治疗费用约为 30,000 美元，并估计与 merus 相关的 NRG1 融合 NSCLC 和 PDAC 的美国销售峰值大约为 1650万美元（基于估计的 8% 特许权使用费率）。
Price Action: MRUS stock is down 3.70% at $43.80 at the last check on Thursday.
价格行动：截至周四最后检查时，MRUS 股票下跌 3.70%，报 43.80 美元。
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译文内容由第三方软件翻译。
