金斯瑞生物科技(01548.HK)附屬處方藥使用者費用法案目標日期延期
金斯瑞生物科技(01548.HK)公佈,非全資附屬傳奇生物指,美國食品和藥物管理局(FDA)已延長了西達基奧侖賽(cilta-cel)的處方藥使用者費用法案的目標日期至2022年2月28日。
該生物製劑許可申請由傳奇生物的合作夥伴Janssen提交。獲延期的初步通知後,傳奇生物及Janssen昨日(1日)與FDA會面,目標日期的延長令FDA有充分的時間審查近期根據FDA信息要求提交的與更新分析方法相關的信息,公司亦未獲要求提供額外臨牀數據。
公司表示,cilta-cel是一種在研的用於治療成人復發或難治性多發性骨髓瘤的靶向的BCMA的嵌合抗原受體T細胞療法。
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