OncoSil FDA approval has opened a US pathway for the company’s radiation device in distal cholangiocarcinoma, according to OncoSil Medical.
The company said the Humanitarian Device Exemption covers adults aged 21 or older. Eligible patients must have unresectable and non-metastatic distal cholangiocarcinoma.
The OncoSil device delivers radioactive phosphorus-32 microparticles directly into a tumour. This approach provides targeted beta radiation at the treatment site, according to the company.
The initial US rollout will involve no more than five treatment centres. Trained clinicians will provide treatment while OncoSil conducts an FDA-mandated post-approval study.
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The prospective multicentre study is expected to enrol 30 patients. Researchers will assess safety and potential clinical benefit for up to 24 months.
OncoSil expects to launch the device in the United States during the second quarter of fiscal 2027. Chief Executive Officer Nigel Lange called the regulatory milestone significant for the company.
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The device previously gained European clearance for locally advanced pancreatic cancer in 2020, according to the supplied report.
