FDA Declines To Approve Merck-Daiichi Sankyo Partnered Lung Cancer Drug
FDA Declines To Approve Merck-Daiichi Sankyo Partnered Lung Cancer Drug
Patritumab deruxtecan is a specifically engineered potential first-in-class HER3-directed DXd antibody-drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed by Daiichi Sankyo and Merck.On Wednesday, the FDA issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) seeking accelerated approval of Daiichi Sankyo (OTC:DSKYF) (OTC:DSNKY) and Merck & Co Inc's (NYSE:MRK) patritumab deruxtecan (HER3-DXd) for adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) previously treated with two or more systemic therapies.
FDA于周三发布了一份生物制品许可申请的完整回应函(CRL)，该许可申请旨在加速批准第一三共(Daiichi Sankyo)和默沙东(Merck)的patritumab deruxtecan(HER3-DXd)，用于治疗先前接受过两种或更多种系统治疗的EGFR突变非小细胞肺癌(NSCLC)的成年患者。
The CRL results from findings about an inspection of a third-party manufacturing facility.
CRL的结果来自对第三方制造设施的检查发现。
The CRL did not identify any issues with the efficacy or safety data submitted.
CRL未发现提交的功效或安全数据存在任何问题。
Patritumab deruxtecan is a specifically engineered potential first-in-class HER3-directed DXd antibody-drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed by Daiichi Sankyo and Merck.
patritumab deruxtecan是由第一三共发现并由第一三共和默沙东共同开发的经过专门设计的潜在HER3定向DXd抗体药物结合物(ADC)。
In December, the FDA accepted and granted Priority Review to the Biologics License Application (BLA) for patritumab deruxtecan (HER3-DXd).
去年12月，FDA接受并优先审核了patritumab deruxtecan(HER3-DXd)的生物制品许可申请(BLA)。
If approved, patritumab deruxtecan would be a first-in-class HER3-directed DXd antibody-drug conjugate for these patients.
如果获准，patritumab deruxtecan将成为这些患者首个HER3定向DXd抗体药物结合物。
"We will work closely with the FDA and the third-party manufacturer to address the feedback as quickly as possible in order to bring the first HER3-directed medicine to patients with previously-treated EGFR-mutated non-small cell lung cancer," said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. "We remain confident in the ability to develop this medicine to its full potential."
第一三共的全球研发负责人菊田健博士表示:"我们将与FDA和第三方制造商密切合作，尽快处理反馈意见，以便将第一个HER3定向药物带给之前接受过系统治疗的EGFR突变非小细胞肺癌患者。我们对开发这种药物的能力保持信心。"
The BLA is based on the primary results from the HERTHENA-Lung01 pivotal phase 2 trial.
BLA是基于HERTHENA-Lung01关键2期试验的初期结果而来。
In HERTHENA-Lung01, patritumab deruxtecan was studied in 225 patients, which demonstrated an objective response rate (ORR) of 29.8%, including one complete response and 66 partial responses.
在HERTHENA-Lung01中，patritumab deruxtecan在225名患者中进行了研究，证明了29.8%的客观反应率(ORR)，包括一种完全反应和66种部分反应。
The median duration of response (DoR) was 6.4 months.
反应持续时间中位数(DoR)为6.4个月。
Price Action: At the last check on Thursday, MRK shares were down 1.04% at $130.14.
价格行动：上周四，默沙东股票收于130.14美元，下跌了1.04%。
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