FDA Grants OncoSil Humanitarian Device Exemption in Distal Cholangiocarcinoma

The FDA has granted a humanitarian device exemption (HDE) approval to an OncoSil device, an intratumoral targeted radiation therapy, for use in patients with unresectable, non-metastatic distal cholangiocarcinoma (dCCA), according to a news release from the company.¹ The approval establishes the device as the only FDA-approved class III device for treating dCCA.

Patients with unresectable, non-metastatic dCCA have a poor prognosis, with a median overall survival of approximately 6.7 months; incidence of the disease is reported to be increasing by approximately 1.4% annually.

“Distal cholangiocarcinoma is a rare and aggressive cancer with a significant need for new therapeutic approaches. The FDA’s HDE approval of this device is an important development, providing eligible US patients and clinicians with an additional treatment option through targeted radiation delivered directly within the tumor,” said Juane Valle, chief medical officer at the Cholangiocarcinoma Foundation, in the press release.¹ “I welcome the opportunity for US specialist centers to gain experience with OncoSil and further understand its role in the multidisciplinary treatment pathway for eligible patients with dCCA.”

What does the FDA approval cover?

The HDE authorizes use of the OncoSil device in patients older than 21 years with dCCA that is unresectable, either because the tumor is locally advanced or the patient is not a surgical candidate, and has non-metastatic disease. The device is intended for use as an adjunct to systemic therapy, and for intratumoral implantation into a solid tumor via injection under endoscopic ultrasound guidance. Implantable components of OncoSil are to be supplied sterile and are intended for single-patient, single-use.

How does the OncoSil device work?

The OncoSil device delivers phosphorus-32 microparticles directly into a tumor via endoscopic ultrasound-guided intratumoral injection, providing localized beta radiation over approximately 3 months while aiming to spare surrounding healthy tissue. Current treatment options for dCCA remain limited and typically include biliary stenting to maintain duct patency alongside systemic therapy and, in select patients, external radiation. The device previously received CE marking in the United Kingdom and European Union and was approved by Australia’s Therapeutic Goods Administration as what the company described as the first and only TGA-approved class III device targeting tumors directly within the pancreas.

What is required as part of the post-approval study?

Under the terms of the HDE, the device’s US rollout will initially be restricted to a maximum of 5 treatment centers with practitioners who have completed required training, as part of an FDA-mandated post-approval study (PAS). The multicenter, prospective PAS will evaluate the safety and probable benefit of the device in up to 30 patients over a 24-month period, with launch planned for the second half of 2027. The study’s final protocol and requirements are expected to be confirmed by the FDA. Each patient enrolled in the PAS is expected to receive a reimbursed treatment.

What did investigators and company leadership say about the approval?

“FDA approval of the OncoSil device under the HDE pathway represents the most significant milestone in OncoSil Medical’s history and a transformational moment for our Company. Most importantly, it provides a pathway making OncoSil available for patients with dCCA in the US, where there remains significant unmet clinical need,” stated Nigel Lange, chief executive officer and managing director of OncoSil Medical, in the press release.¹ “Our attention now turns to successfully launching OncoSil in the US. We will work with leading cancer centers and clinical teams to establish treatment sites, advance reimbursement and market access, and build the foundations for sustainable adoption. This approval marks the beginning of an exciting new chapter for OncoSil Medical as we work to make a meaningful difference to patients facing this challenging cancer.”

References

OncoSil receives FDA approval for distal cholangiocarcinoma. News release. OncoSil Medical Ltd. August 17, 2026. Accessed August 17, 2026. https://tinyurl.com/av2rdsah