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In A First, FDA Approves Radioembolization Treatment For Liver Cancer In US

 
• By Phil Greenfield

Approval for Boston Scientific’s TheraSphere offers further access to the therapy that, until now, has only been available under a humanitarian device exemption.

Liver cancer

The US Food and Drug Administration has approved Boston Scientific Corporation’s TheraSphere microsphere-based treatment for unresectable advanced hepatocellular carcinoma (HCC). The FDA approval means TheraSphere is the only radioembolization technology indicated for the treatment of unresectable HCC in the US. The approval expands access to the life-prolonging therapy for a greater number of patients, which, to date, has been used under a humanitarian device exemption – this required institutional review board approval and limited the number of patients treated per year.

The American Cancer Society estimates that approximately 32,000 new cases of HCC will be diagnosed in the US in 2021....

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