Boston Scientific (NYSE:BSX) announced today that it received FDA approval for its TheraSphere Y-90 glass microspheres.
Marlborough, Mass.–based Boston Scientific’s TheraSphere Y-90 glass microspheres were developed to treat those with hepatocellular carcinoma (HCC), according to a news release.
Approval for the technology offers further access to the therapy that, until now, has been utilized under a humanitarian device exemption. Boston Scientific said it is now the only radioembolization technology indicated for treating unresectable HCC in the U.S.
TheraSphere provides a type of selective internal radiation therapy (SIRT) with low toxicity, comprised of millions of microscopic glass beads containing radioactive yttrium (Y-90). The glass beads are delivered directly to liver tumors via a catheter to ensure minimal exposure to surrounding healthy tissue.
The Legacy study of 162 participants that evaluated the therapy’s safety and efficacy for treating early and advanced HCC reached both primary endpoints of objective response rate and duration of response rate. Results showed 100% complete or partial patient response up to two TheraSphere treatments and a 93% overall survival rate in patients with transplant or resection following treatment at three years.
Hospitalization is not required for a patient treated with TheraSphere, as treatments can be performed as an outpatient procedure in as little as one hour.
“The FDA approval and the recent NICE recommendation will expand access to TheraSphere, which has demonstrated improvement in both survivability and quality of life through 20 years of clinical trials and real-world outcomes in the more than 70,000 patients globally,” Boston Scientific president of interventional oncology, peripheral interventions Peter Pattison said in the release. “We expect to continue to focus our efforts on bringing this treatment to more patients, both by planning a randomized trial to study the combination of TheraSphere and immunotherapy in patients with HCC not eligible for curative treatments, as well as further investigating the therapy for different cancer segments, including prostate and brain.”