FDA Investigating Serious Risk Of Hematologic Malignancy Following Skysona (Elivaldogene Autotemcel)
FDA Investigating Serious Risk Of Hematologic Malignancy Following Skysona (Elivaldogene Autotemcel)
WARNING: HEMATOLOGIC MALIGNANCY Hematologic malignancy, including life-threatening cases of myelodysplastic syndrome, has occurred in patients treated with SKYSONA. Patients have been diagnosed between 14 months and 7.5 years after SKYSONA administration, and the cancers appear to be the result of the SKYSONA lentiviral vector, Lenti-D, integration in proto-oncogenes. Monitor patients closely for evidence of malignancy through complete blood counts at least every 6 months and through assessments for evidence for clonal expansion or predominance at least twice in the first year and annually thereafter; consider bone marrow evaluations as clinically indicated [see Warnings and Precautions (5.1)].
警告：血液系统恶性肿瘤 服用SKYSONA的患者中出现了包括有生命危险的骨髓增生异常综合症在内的血液系统恶性肿瘤。患者在接受SKYSONA治疗后14个月至7.5年之间被确诊，这些癌症似乎是由SKYSONA慢病毒载体Lenti-D在原癌基因中整合所致。密切监测患者是否有恶性肿瘤的迹象，至少每6个月进行完整血细胞计数，并且在第一年至少两次及以后每年考虑骨髓评估（根据临床情况所需）[请参阅警告和注意事项(5.1)]。
