FDA Declines To Approve Merck-Daiichi Sankyo Partnered Lung Cancer Drug
FDA Declines To Approve Merck-Daiichi Sankyo Partnered Lung Cancer Drug
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於週三發佈了一份生物製品許可申請的完整回應函(CRL)，該許可申請旨在加速批准第一三共(Daiichi Sankyo)和默沙東(Merck)的patritumab deruxtecan(HER3-DXd)，用於治療先前接受過兩種或更多種系統治療的EGFR突變非小細胞肺癌(NSCLC)的成年患者。
The CRL results from findings about an inspection of a third-party manufacturing facility.
CRL的結果來自對第三方製造設施的檢查發現。
The CRL did not identify any issues with the efficacy or safety data submitted.
CRL未發現提交的功效或安全數據存在任何問題。
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是由第一三共發現並由第一三共和默沙東共同開發的經過專門設計的潛在HER3定向DXd抗體藥物結合物(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接受並優先審核了patritumab deruxtecan(HER3-DXd)的生物製品許可申請(BLA)。
If approved, patritumab deruxtecan would be a first-in-class HER3-directed DXd antibody-drug conjugate for these patients.
如果獲准，patritumab deruxtecan將成爲這些患者首個HER3定向DXd抗體藥物結合物。
"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."
第一三共的全球研發負責人菊田健博士表示:"我們將與FDA和第三方製造商密切合作，儘快處理反饋意見，以便將第一個HER3定向藥物帶給之前接受過系統治療的EGFR突變非小細胞肺癌患者。我們對開發這種藥物的能力保持信心。"
The BLA is based on the primary results from the HERTHENA-Lung01 pivotal phase 2 trial.
BLA是基於HERTHENA-Lung01關鍵2期試驗的初期結果而來。
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名患者中進行了研究，證明了29.8%的客觀反應率(ORR)，包括一種完全反應和66種部分反應。
The median duration of response (DoR) was 6.4 months.
反應持續時間中位數(DoR)爲6.4個月。
Price Action: At the last check on Thursday, MRK shares were down 1.04% at $130.14.
價格行動：上週四，默沙東股票收於130.14美元，下跌了1.04%。
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譯文內容由第三人軟體翻譯。