Hemophilia B Gene Therapy AMT-061 Unlikely to Have Caused Liver Tumor

Hemophilia B Gene Therapy AMT-061 Unlikely to Have Caused Liver Tumor

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Hemophilia B Gene Therapy AMT-061 Unlikely to Have Caused Liver Tumor

AMT-061 (etranacogene dezaparvovec), uniQure’s investigational gene therapy for hemophilia B, likely did not cause the case of hepatocellular carcinoma (HCC) — a form of liver cancer — that led to the program’s clinical hold in December 2020, an investigation has found. The U.S. Food and Drug Administration (FDA) had put the AMT-061 program on hold after the case of HCC was detected in a participant in the Phase 3 HOPE-B trial, which was testing the gene therapy in people…

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