On Wednesday, the FDA approved Merus N.V.’s 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..

周三，FDA批准Merus N.V.的MRUS Bizengri（zenocutuzumab zbco）作为第一种也是唯一一种治疗胰腺癌或非小细胞肺癌（NSCLC）的方法，这些患者是晚期不可切除或转移的，并且携带神经调节蛋白1（NRG1）基因融合，在先前的全身治疗时或之后有疾病进展。。

Bizengri is Merus’s first approved medicine and is based on the proprietary Biclonics technology platform.

Bizengri是Merus的第一种经批准的药物，基于专有的双克隆技术平台。

Also Read: Merus Licenses US Commercialization Rights For Cancer Potential Zenocutuzumab, Analyst Highlight Merus’ Pipeline

另请阅读：Merus许可美国潜在癌症Zenocutuzumab的商业化权利，分析师强调Merus的管道

These indications are approved under accelerated approval based on the overall response rate (ORR) and duration of response (DOR).

这些适应症是根据总体缓解率（ORR）和缓解持续时间（DOR）在加速批准下批准的。

Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

继续批准这些适应症可能取决于验证性试验中临床益处的验证和描述。

Bizengri 20 mg/mL Injection for Intravenous Use is expected to be available to patients in the coming weeks.

Bizengri 20 mg/mL静脉注射预计将在未来几周内提供给患者。

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的批准是基于eNRGy试验的数据。在NRG1+胰腺癌患者（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.

NRG1+胰腺癌的DOR范围为3.7个月至16.6个月。在同一试验中，用Bizengri治疗的NRG1+NSCLC患者（n=64）的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，“投资者的重点仍然是哌妥司他单抗，该公司的下一个关键催化剂是12月7日在ESMO Asia上更新哌妥司他单抗在先前治疗的头颈部鳞状细胞癌（HNSCC）中的数据。”

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.

该分析师假设Bizengri的每种治疗定价约为30000美元，并估计NRG1 fusion NSCLC和PDAC的美国销售额峰值（基于估计的8%特许权使用率）约为1650万美元。

Price Action: MRUS stock is down 3.70% at $43.80 at the last check on Thursday.

价格走势：周四最后一次检查显示，MRUS股价下跌3.70%，至43.80美元。

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