Boston Scientific Gets FDA Approval for TheraSphere Y-90 Glass Microspheres
March 18 2021 - 8:00AM
Dow Jones News
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 michael.dabaie@wsj.com
(END) Dow Jones Newswires
March 18, 2021 07:45 ET (11:45 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
Boston Scientific (NYSE:BSX)
Historical Stock Chart
From Mar 2024 to Apr 2024
Boston Scientific (NYSE:BSX)
Historical Stock Chart
From Apr 2023 to Apr 2024