信達生物(01801.HK):美國就治療肺癌新藥上申請召開委員會審評
信達生物(01801.HK)公佈,美國食物藥品監督管理局召開腫瘤藥物諮詢委員會(ODAC),對信迪利單抗注射液的新藥上市申請(BLA)審評問題進行討論並投票。
此次BLA申報適應症爲信迪利單抗注射液聯合培美曲塞和鉑類用於非鱗狀非小細胞肺癌(nsqNSCLC)一線治療,主要基於在中國開展的ORIENT-11臨牀三期試驗資料。委員會投票建議需要在獲批前補充額外臨牀試驗,證明信迪利單抗在美國人羣和美國醫療實踐中的適用性。
信迪利單抗是一款創新PD-1抑制劑,由公司與禮來製藥共同開發和商業化。ORIENT-11試驗結果數據展示信迪利單抗的良好的風險獲益關係。FDA沒有任何對於信迪利單抗安全性和有效性問題的質疑。公司和禮來製藥將繼續與FDA配合完成新藥上市申請的審評工作。
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