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Home » Hemophilia Gene Therapy Trial Put on Hold After Patient Develops Cancer
Hemophilia Gene Therapy Trial Put on Hold After Patient Develops Cancer
The FDA has placed a clinical hold on uniQure’s entire clinical development program for its investigational gene therapy for hemophilia B after a patient participating in a pivotal phase 3 clinical trial was given a preliminary diagnosis of liver cancer, the company announced Monday. The serious adverse event was included in a mid-December safety report on the trial as being possibly related to the patient’s treatment with the investigational gene therapy, etranacogene dezaparvovec (AMT-061) in October 2019.