Boston Scientific Gets FDA Approval for TheraSphere Y-90 Glass Microspheres

By Michael Dabaie

Boston Scientific Corp. said it received U.S. Food and Drug Administration approval for TheraSphere Y-90 Glass Microspheres, developed for the treatment of patients with hepatocellular carcinoma.

The approval expands access to the therapy for a greater number of patients, which, to date, has been utilized under a humanitarian device exemption. That is an FDA classification which required institutional review board approval and limited the number of patients treated with the therapy per year, the company said.

HCC is one of the most prevalent cancers in the world and the most common type of primary liver cancer, with more than half a million new global cases diagnosed annually, Boston Scientific said.

Approval of TheraSphere was based on results from the LEGACY study, designed to evaluate the safety and efficacy of the therapy for the treatment of early and advanced HCC. The study analyzed data from 162 patients and met both primary endpoints of objective response rate and duration of response rate, the company said.

Write to Michael Dabaie at [e-mail]

(END) Dow Jones Newswires

March 18, 2021 07:45 ET (11:45 GMT)

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