金斯瑞(01548.HK):傳奇生物CARVYKTI美國標籤更新 添加警告信息
金斯瑞生物科技(01548.HK)公布,其非全資附屬傳奇生物(LEGN.US)獲美國食品和藥物管理局(FDA)批准CARVYKTI的標籤更新,以納入CARTITUDE-1研究長期隨訪(中位持續時間為28個月)的額外療效和安全性信息。
公司指出,在本次標籤更新中,美國處方信息的方框警告中添加了「繼發性血液系統惡性腫瘤,包括骨髓增生異常綜合症和急性髓系白血病,在CARVYKTI治療後發生。」
在CARTITUDE-1研究中,10%(10/97)的患者在接受CARVYKTI治療後發生髓系腫瘤的觀察結果。CARVYKTI治療後,髓系腫瘤發作的中位時間為485天(範圍:162至1,040天)。該10名患者中有9名在發生骨髓腫瘤後死亡。10例髓系腫瘤中有4例發生在後續抗骨髓瘤治療開始後。骨髓增生異常綜合症和急性髓系白血病的病例在上市後環境中也有報道。
該10名患者接受了多重既往治療,中位數為7.5線既往治療(範圍:4至18線)。其中一些患者在接受CARVYKTI之前就存在基因突變。CARVYKTI與髓系腫瘤發展之間的潛在機制尚未確定。
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