UTRECHT, The Netherlands and CAMBRIDGE, Mass., May 06, 2024 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®), today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review a Biologics License Application (BLA) for the bispecific antibody zenocutuzumab (Zeno) in patients with neuregulin 1 fusion (NRG1+) non-small cell lung (NSCLC) and NRG1+ pancreatic (PDAC) cancer.

荷兰乌得勒支和马萨诸塞州剑桥，2024年5月6日（环球通讯社）--Merus N.V.（纳斯达克：MRUS）（Merus，The Company，we，or our），一家开发创新的全长多特异性抗体（Biclonics®和Triclonics®）的临床阶段肿瘤公司，今天宣布，美国食品和药物管理局（FDA）已接受对神经调节蛋白1融合（NRG1+）非小细胞肺癌（NSCLC）和NRG1+胰腺癌（PDAC）患者双特异性抗体zenocutuzumab（Zeno）的生物制剂许可证申请（BLA）进行优先审查。

“FDA acceptance of our first BLA represents an important achievement for Merus and an important potential treatment opportunity for patients with NRG1+ cancer, a disease with poor prognosis and high unmet need,” said Dr. Andrew Joe, Chief Medical Officer at Merus. “Zenocutuzumab has the potential to be the first and only targeted therapy for patients with NRG1+ lung and pancreatic cancer, and may offer a substantial improvement over currently available therapies.” The BLA includes a comprehensive clinical data package, including data from the phase 1/2 eNRGy trial, which is investigating the safety and anti-tumor activity of Zeno monotherapy in NRG1+ NSCLC, PDAC and other solid tumors.

Merus首席医疗官AndrewJoe博士说：“FDA接受我们的第一个BLA代表了Merus取得的重要成就，也是NRG1+癌症患者的重要潜在治疗机会，NRG1+癌症是一种预后不良且需求未得到满足的疾病。”。“Zenocutuzumab有可能成为NRG1+肺癌和胰腺癌患者的第一个也是唯一的靶向治疗方法，并且可能比目前可用的治疗方法有实质性改进。”BLA包括一个全面的临床数据包，包括来自1/2期eNRGy试验的数据，该试验正在研究Zeno单药治疗NRG1+NSCLC，PDAC和其他实体瘤的安全性和抗肿瘤活性。

Data from the open-label trial were presented previously at the American Society of Clinical Oncology (ASCO) 2021 Annual Meeting, and subsequently updated at ASCO 2022 and the European Society for Medical Oncology (ESMO) Congress 2023. The FDA has granted Breakthrough Therapy Designation (BTD) to Zeno for the treatment of patients with advanced unresectable or metastatic NRG1+ pancreatic cancer following progression with prior systemic therapy or who have no satisfactory alternative treatment options.

开放标签试验的数据先前已在美国临床肿瘤学会（ASCO）2021年年度会议上提交，随后在ASCO 2022年和欧洲医学肿瘤学会（ESMO）2023年大会上更新。FDA已授予Zeno突破性治疗指定（BTD），用于治疗先前全身治疗进展或没有令人满意的替代治疗选择的晚期不可切除或转移性NRG1+胰腺癌患者。

Additionally, the FDA has granted BTD .

此外，FDA已批准BTD。